WHO Drug Information Vol. 29, No. 4, 2015

Regulatory news

Pre-market assessment (4) “Adaptive licensing” or “adaptive pathways”: Deregulation under the guise of earlier access. Joint briefing paper. Brussels: Accelerated access pathways in HAI, ISDB, MiEF; 16 October 2015. Europe European Union – The EMA has sought Regulatory systems public comments on its revised guidelines on the implementation of accelerated New Zealand working on new assessment and conditional marketing regulatory regime authorization (1). The revised guidelines New Zealand – The New Zealand provide more details on how to justify Government is working on a new and fulfilment of a major public health interest comprehensive national regulatory and on the importance of planning and regime to regulate therapeutic products, early dialogue. More recently, EMA has i.e. the wide range products intended also launched a public consultation on its to be used in or on human beings for a new proposed PRIME scheme to optimize therapeutic purpose including medical development of priority medicines and devices and cell and tissue therapies, facilitate patients’ access (2). which are currently not fully regulated in In their public input to the former New Zealand. This follows the cessation consultation process (3), Health Action of the Australia New Zealand Therapeutic International (HAI), the International Products Agency (ANZTPA) project. The Society of Drug Bulletins (ISDB) and intention is for a Bill to be introduced to the Medicines in Europe Forum (MiEF) Parliament in 2016. have emphasized the importance of ►►New Zealand Ministry of Health. Web page, concrete evidence demonstrating a new updated 16 September 2015. drug’s safety and therapeutic advance, of enforcing compliance with post-market obligations, and of ensuring transparency Post-marketing control of accelerated decision-making by making assessment reports and expert EMA initiative to improve patient statements publicly available. The three registries organizations have further published a European Union – The EMA has joint briefing paper, in which they caution launched an initiative aimed at making against adaptive pathways becoming the better use of patient registries as a source rule even when no genuine public health of high-quality post-authorization data on need exists (4). medicines in clinical use. ►►(1) EMA News, 27 July 2015. Registries collect information over (2) EMA News, 26 October 2015. time on patients who are diagnosed (3) HAI, ISDB, MiEF. Joint response to EMA with a particular disease or who receive public consultation. 30 September 2015. particular treatments. Some registries are kept by pharmaceutical companies as a

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regulatory requirement, while others are affected by ICH harmonization. ICH operated at national or international levels aims to be the leading platform for global for example by physicians’ associations or pharmaceutical regulatory harmonisation, national agencies. Existing registries are bringing together in a transparent manner not sufficiently coordinated or harmonized, all key regulatory authorities and industry leading to inefficiencies. stakeholders. The ICH operating structure The initiative is managed by a cross- will be an association under Swiss law, committee task force and includes two which establishes the new Assembly as components: a collaborative strategy the overarching governing body. and a pilot phase. The strategy aims ►►ICH Press release, 26 October 2015. to facilitate the interactions between coordinators of registries, regulators and pharmaceutical companies, and to identify China and WHO collaborate on methodological components for newly medicines quality established registries to ensure that high Geneva – The long-standing collaboration quality and relevant data are collected. between China and WHO to promote The pilot phase aims to test whether the access to good quality pharmaceuticals strategy meets stakeholders’ needs on the was formalized in September 2015 when basis of real-life examples. It is anticipated the Chinese Food and Drug Authority to last for two years. Participation will be (CFDA) and WHO signed a ‘cooperation determined on a case-by-case basis by plan’ at WHO headquarters. The plan the cross-committee task force. sets out a comprehensive package of ►►EMA News, 12 October 2015. measures that China will undertake with WHO’s technical assistance, specifically to improve the quality of generic medicines, Collaboration and harmonization create a more science based and efficient review and approval system, reduce ICH announces organizational drug submission backlogs and promote changes transparency of operations. Geneva – The International Council ►►WHO Essential medicines and health for Harmonisation (ICH), formerly products. China – growing potential to known as the International Conference supply affordable quality medicines [web on Harmonisation, has announced page]. organizational reforms to equip it better to face the challenges of global pharmaceutical development and Meeting of World Pharmacopoeias regulation. held in China The reforms aim to expand ICH beyond China – The 6th International Meeting of the current membership to make it a truly World Pharmacopoeias was co-hosted global initiative. Regulators around the by the Chinese Pharmacopoeia world will be invited to join counterparts (ChP) and WHO in Suzhou, China, from Europe, Japan, USA, Canada and on 21–22 September 2015. Achieving Switzerland as ICH regulatory members. global standards to expand access to This is matched by the possibility of quality medicines globally was key to the wider inclusion of global industry sectors discussions of the meeting, which was

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held in connection with the 2015 ChP the medicines sold in the United Kingdom Annual Scientific Symposium. Twelve are made in India. The agreement is part pharmacopoeias from all around the of a concerted effort to promote good globe attended, including the European manufacturing practices throughout the Pharmacopoeia on behalf of its 38 pharmaceutical industry, benefitting the signatories. global public. Similar agreements are An important output of this international already in place between MHRA and meeting was the finalization of the first- counterpart bodies in China and America. ever guideline on Good Pharmacopoeial ►►MHRA Press release, 5 October 2015. practices, based on feedback received during wide global consultation, for presentation to the WHO Expert EMA and WHO share non-public Committee on Specifications for information Pharmaceutical Preparations. The European Union – The European Committee’s adoption of this guideline Commission, EMA and WHO have at its 50th meeting in October 2015 (see concluded a working arrangement that also page 481) marks a significant allows timely sharing of non-public step forward in setting globally unified information on the safety, quality and principles for creating quality standards for efficacy of medicines already authorized medicines. or under review in the European Union ►►WHO Essential medicines and health (EU), or prequalified or under review products. Meeting of World Pharmacopoeias by WHO. This cooperation started on in China benefits the world’s [web page]. 1st September 2015. The arrangement will make it easier and quicker to communicate and take action Regulators of United Kingdom and to protect public health. Examples of India sign agreement information that may be shared include: New Delhi – The Medicines and • pharmacovigilance data, particularly Healthcare products Regulatory Agency urgent information on EU-originating or (MHRA) and the Central Drugs Standard non-EU originating adverse reactions; Control Organisation (CDSCO) under the • information on applications for scientific Ministry of Health and Family Welfare advice, orphan medicine designation, of the Republic of India have signed marketing authorization, post- a Memorandum of Understanding authorization activities of significant (MOU). The agreement aims to facilitate public health interest, and applications regulatory information exchange and for agreement of paediatric investigation technical cooperation of mutual benefit, plans; and helping to protect the health and public • data and reports related to inspections, safety in the two countries. manufacturing facilities and clinical In 2014, MHRA carried out 125 research activities. inspections in non-EU countries, 49 of ►►EMA News, 22 September 2015. which were in India. Approximately 25% of

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Approved Safety information: Hypersensitivity reactions have been reported rarely.

Insulin degludec & insulin aspart: for ►►EMA/CHMP Summary of opinion, diabetes mellitus 24 September 2015. Product name: Ryzodeg 70/30® Dosage form: Injection Class: Combination of a long-acting insulin Modified antihaemophilic factor analog (insulin degludec) and a rapid- (recombinant) acting human insulin analog (insulin Product name: Adynovate® aspart): ATC code: A10AD06 Dosage form: Lyophilized powder for solution Approval: FDA for intravenous injection. Use: Improvement of glycaemic control in Class: Blood coagulation factor adults with type 1 and 2 diabetes mellitus Approval: FDA Benefits: Additional treatment option Use: On-demand treatment and control for diabetes; ability to reduce HbA1c of bleeding episodes for prophylaxis in equivalent to reductions achieved with patients with haemophilia A. FDA-approved long-acting or pre-mixed Benefits: This PEGylated product potentially insulin products. requires less frequent injections than Safety information: The product should unmodified antihaemophilic factor. not be used in patients with diabetic ►►FDA News release, 13 November 2015. ketoacidosis. Like other insulins, it may cause severe, life-threatening,

generalized allergy, including anaphylaxis, Coagulation Factor X (human): for generalized skin reactions, angioedema, hereditary Factor X deficiency bronchospasm, hypotension, and shock, Product name: Coagadex® as well as hypoglycaemia which can be Class: Blood coagulation factor; life-threatening. ATC code: B02BD13 Notes: The FDA has also approved insulin Approval: FDA (orphan designation) degludec (Tresiba®) which was approved Use: Treatment of individuals aged 12 and by EMA in 2013. older with hereditary Factor X deficiency ►►FDA News release, 25 September 2015. for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in patients with

Efmoroctocog alfa: for haemophilia A mild hereditary Factor X deficiency. Product name: Elocta® Benefits: The availability of a purified Dosage form: Powder and solvent for solution Factor X concentrate increases treatment for injection options for patients with this rare Class: Antihaemorrhagic (ATC code: B02) hereditary condition. Approval: EMA (orphan designation) ►►FDA News release, 20 October 2015. Use: Treatment and prophylaxis of bleeding in patients with haemophilia A

Benefits: provide adequate prophylaxis in Patiromer : for hyperkalaemia terms of annualised bleeding Product name: Veltassa® Benefits: Ability to provide adequate Dosage form: Powder for oral suspension prophylaxis in terms of annualised Class: Potassium binder; polymer bleeding rate, to control bleeding on Approval: FDA demand and to provide haemostatic Use: Treatment of hyperkalaemia. Not efficacy for surgical procedures. appropriate for rapid correction of severe

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Approved

hyperkalaemia as lowering of serum blood count disorders and urinary tract potassium may take hours to days. obstruction due to the formation of orotic Benefits: In clinical trials, patiromer was acid crystals, resulting in failure to thrive effective in lowering potassium levels in and developmental delays. hyperkalaemic participants with chronic Benefits: Uridine replacement; stabilisation of kidney disease taking one or more renin- the haematologic parameters. angiotensin-aldosterone system inhibitors. ►►FDA News release, 4 September 2015. Safety information: Patiromer binds many other orally administered drugs, which

could decrease their absorption and Trifluridine & tipiracil: for advanced reduce their effects. It should be taken at colorectal cancer least six hours before or after any other Product name: Lonsurf® orally administered medication. Dosage form: Tablet ►►FDA News release, 21 October 2015. Class: combination of a nucleoside metabolic inhibitor (trifluridine) and a thymidine phosphorylase inhibitor (tipiracil); Elvitegravir & cobicistat & ATC code: L01BC59 emtricitabine & tenofovir alafenamide : Approval: FDA for HIV infection Use: Treatment of patients with advanced Product name: Genvoya® (metastatic) colorectal cancer who Dosage form: Film-coated tablet have been previously treated with Class: Antiretroviral, fixed-dose combination; chemotherapy and biological therapy. ATC code: J05AR18 Benefits: Additional treatment option for Approval: EMA metastatic colorectal cancer. Use: Treatment of adults and adolescents Safety information: Risk of severe infected with human immunodeficiency myelosuppression. Complete blood counts virus 1 without any known mutations should be obtained before starting each associated with resistance to the integrase treatment cycle, and patients should be inhibitor class, emtricitabine or tenofovir monitored throughout treatment. Benefits: Potent antiretroviral response in Women should be advised of potential a once daily, single pill regimen; lower risks to developing foetuses. Women on impact on renal safety and bone mineral treatment with this product should not density than tenofovir disoproxil. breastfeed. ►►EMA/CHMP Summary of opinion, ►►FDA News release, 22 September 2015. 24 September 2015.

Blinatumomab: for certain acute

Uridine triacetate : for a rare hereditary lymphoblastic leukaemias metabolic disorder Product name: Blincyto® Product name: Xuriden® Dosage form: Powder in a vial for preparing Dosage form: Oral granules a concentrate for solution for infusion, and Class: Nucleoside stabilising solution Approval: FDA (orphan drug designation) Class: Bispecific T-cell engager antibody; Use: Treatment of hereditary orotic aciduria, ATC code: L01XC19 a very rare metabolic disorder that Approval: EMA (conditional marketing prevents the body from synthesizing authorization; orphan designation) uridine, a necessary component of Use: Treatment of adults with Philadelphia ribonucleic acid (RNA). This causes chromosome-negative relapsed or

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Approved

refractory B-precursor acute lymphoblastic mutation, compared with vemurafenib leukaemia. monotherapy. Benefits: Ability to increase the proportion of Safety information: May cause severe patients who have complete remission and side effects including cardiomyopathy, molecular remission within the first two rhabdomyolysis, new skin tumours, retinal treatment cycles. detachment, liver damage, bleeding and ►►EMA CHMP Summary of opinion, severe skin rash due to photosensitivity. 24 September 2015. Women taking cobimetinib should use effective contraception. Notes: The product was first approved by

Necitumumab : for advanced Swissmedic in August 2015. squamous non-small cell lung cancer ►►EMA CHMP Summary of opinion, Product name: Portrazza® 24 September 2015. Dosage form: FDA News release, 10 November 2015. Class: monoclonal antibody, EGFR-blocker: ATC code: L01XC22

Approval: FDA Irinotecan liposome injection: for Use: Treatment of patients with advanced advanced pancreatic cancer (metastatic) squamous non-small cell lung Product name: Onivyde® cancer who have not previously received Dosage form: Liposome injection medication specifically for this cancer. Class: Antineoplastic agent; Benefits: New treatment option for certain ATC code: L01XX19 patients with squamous cell lung cancer, Approval: FDA (orphan designation; priority ability to extend survival. review) Safety information: The product carries Use: In combination with fluorouracil and a boxed warning to alert health care leucovorin, to treat patients with advanced providers about serious risks of cardiac (metastatic) pancreatic cancer who have arrest and sudden death, as well as been previously treated with gemcitabine- hypomagnesaemia with potentially fatal based chemotherapy. outcomes. Benefits: Longer survival period, compared ►►FDA News release, 24 November 2015. to patients treated with fluorouracil and leucovorin only. Safety information: The medicine carries a

Cobimetinib: for metastatic melanoma Boxed Warning about the risks of severe Product name: Cotellic® neutropenia and diarrhoea. Death due to Dosage form: Film-coated tablets sepsis following neutropenia has been Class: Antineoplastic agent; mitogen- reported in patients treated with irinotecan. activated protein kinase (MAPK) pathway The medicine is not FDA-approved for use inhibitor (ATC code: L01XE) as a single agent. Approval: EMA, FDA (priority review; orphan ►►FDA Press announcement, 22 October drug designation) 2015. Use: In combination with vemurafenib, treatment of unresectable or metastatic

melanoma in patients with a BRAF V600 Carfilzomib: for a rare type of blood mutation cancer Benefits: Longer progression-free survival Product name: Kyprolis® in melanoma patients with a BRAFV600 Dosage form: Powder for solution for injection

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Approved

Class: Irreversible proteasome inhibitor; Benefits: Increased durable response rate – ATC code: L01XX45 defined as disappearance of the tumours Approval: EMA (accelerated assessment, or at least 50% reduction of tumours orphan designation) lasting at least six months – compared Use: In combination with lenalidomide to treatment with the immune stimulatory and dexamethasone, treatment of adult protein human GM-CSF. The product has patients with multiple myeloma who have not been shown to improve overall survival received at least one prior therapy. or to have an effect on melanoma that has Benefits: More sustained inhibition of spread to the brain, bone, liver, lungs, or targeted proteasome with minimal other internal organs. inhibition of other non-targeted enzymes; Safety information: This product is a modified longer progression-free interval. live oncolytic herpes virus therapy, Safety information: Serious side effects therefore herpes virus infection can include blood abnormalities and cardiac occur. Given this, the product should events. A follow-up plan was approved not to be used in patients who are to monitor the safety and efficacy of immunocompromised, or in pregnant carfilzomib. women. ►►EMA Press release, 25 September 2015. ►►EMA Press release, 23 October 2015. FDA News release, 27 October 2015.

Ixazomib: for multiple myeloma

Product name: Ninlaro® Mepolizumab: for asthma Dosage form: Capsule Product name: Nucala® Class: Antineoplastic – first oral proteasome Dosage form: Powder for solution for injection inhibitor; ATC code: L01XX50 Class: Humanised monoclonal antibody Approval: FDA (orphan drug designation; targeting human interleukin‑5; priority review) ATC code: L04AC06 Use: In combination lenalidomide and Approval: EMA, FDA dexamethasone, to treat patients with Use: Treatment of patients 12 years and multiple myeloma who have received at older with severe refractory eosinophilic least one prior therapy. asthma. Benefits: New oral treatment with ability to Benefits: Can reduce the number of asthma slow disease progression when other exacerbations in patients who either therapy has failed. remain uncontrolled on their previous ►►FDA News release, 20 November 2015. standard of care or who are dependent on systemic corticosteroids. Safety information: Hypersensitivity reactions

Talimogene laherparepvec : for can occur within hours or days of advanced melanoma treatment. Product name: Imlygic® ►►EMA/CHMP Summary of opinion, Dosage form: Solution for injection 24 September 2015. Class: Oncolytic virus derived from HSV-1 (a FDA News release, 4 November 2015. first-in-class advanced therapy medicinal product)

Approval: EMA, FDA Osimertinib: for certain non-small cell Use: Treatment of adults with unresectable lung cancers melanoma. The product is directly injected Product name: Tagrisso® into lesions in the skin or lymph nodes. Dosage form: Tablet

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Approved

Class: Third-generation tyrosine kinase Cariprazine : for schizophrenia and inhibitor bipolar disorder Approval: FDA (breakthrough therapy Product name: Vraylar® designation, priority review and orphan Dosage form: Capsules drug designation; accelerated approval. Class: Antipsychotic, ATC code: N05AX15 Continued approval for this indication may Approval: FDA be contingent upon further confirmatory Use: Treatment of schizophrenia and bipolar studies.) disorder in adults Use: Treatment of patients with advanced Benefits: Reduction of symptoms of non-small cell lung cancer whose tumours schizophrenia and bipolar disorder have the T790M epidermal growth factor Safety information: As all other FDA- receptor (EGFR) mutation and have approved products for treatment of progressed on or after treatment with other schizophrenia and bipolar disorder, the EGFR-blocking therapy. product has a Boxed Warning about an Benefits: Reduction of tumour size was increased risk of death associated with observed in more than half of the patients the use of these drugs in older people treated in two clinical trials. with dementia-related psychosis. Neither Safety information: May cause serious side cariprazine nor any other drug in this class effects, including inflammation of the lungs is approved to treat such patients. and injury to the heart. May cause harm to ►►FDA News release, 17 September 2015. a developing foetus. Notes: The FDA also approved a companion

diagnostic test (cobas EGFR Mutation Test Pitolisant: for narcolepsy v2) to detect the T790M mutation. Product name: Wakix® ►►FDA News release, 13 November 2015. Dosage form: Film-coated tablets Class: Antagonist/inverse agonist of the histamine H3 receptor (first-in-class);

Daratumumab : for multiple myeloma ATC code: N07XX11 Product name: Darzalex® Approval: EMA (orphan designation) Dosage form: Injection for intravenous use Use: Treatment of adult patients with Class: Antineoplastic; human CD38-directed narcolepsy with or without cataplexy. monoclonal antibody Narcolepsy is a rare, long-term sleep Approval: FDA (breakthrough therapy disorder which affects the brain’s ability designation, priority review and orphan to regulate the normal sleep-wake cycle, drug designation; accelerated approval) and may occur with or without cataplexy Use: Treatment of treat patients with multiple (sudden severe muscle weakness or loss myeloma who have received at least three of muscle control). prior treatments. Benefits: Ability to reduce excessive daytime Benefits: Ability to achieve complete or sleepiness in patients with narcolepsy, and partial reduction in tumour burden. to decrease cataplexy rate. Safety information: Daratumumab may cause ►►EMA Press release, 20 November 2015. serious infusion reactions. Daratumumab may interfere with certain tests that are

done by blood banks (such as antibody Naloxone nasal spray : for opioid screening) for patients who need a blood overdose transfusion. Product name: Narcan® ►►FDA News release, 16 November 2015. Dosage form: Nasal spray Class: Antidote; ATC code: V03AB15

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Approved

Approval: FDA (fast-track designation, hyperkalaemic participants with chronic priority review) kidney disease taking one or more renin- Use: To reverse the effects of an opioid angiotensin-aldosterone system inhibitors. overdose. Safety information: Patiromer binds many Benefits: Easier to deliver than injectable other orally administered drugs, which dosage form, with no risk of a could decrease their absorption and contaminated needle stick. reduce their effects. It should be taken at ►►FDA News release, 18 November 2015. least six hours before or after any other orally administered medication. ►►FDA News release, 21 October 2015.

Idarucizumab: for reversal of dabigatran anticoagulant effect Product name: Praxbind® EMA Article 58 positive opinion Dosage form: Solution for injection/infusion Class: Humanised monoclonal antibody Pyronaridine-artesunate – fragment; ATC code: V03AB paediatric antimalarial formulation Approval: EMA Product name: Pyramax® Use: Indicated in adult patients treated with Additional dosage form: Granules for oral dabigatran etexilate (Pradaxa®) when suspension rapid reversal of the latter’s anticoagulant Class: Antimalarial, artemisinin combination effects is required: (1) for emergency therapy surgery/urgent procedures or (2) In life- Approval: EMA positive opinion under threatening or uncontrolled bleeding. For Article 58. This programme allows the hospital use only. EMA to assess and give a scientific Benefits: Ability to reverse the anticoagulant opinion in cooperation with the World effect of dabigatran within 5 minutes Health Organization (WHO) for medicines of administration, enabling clinical intended exclusively for markets outside emergency management of patients if the European Union (EU). Through this needed. Does not interfere with routine mechanism, regulators outside the EU can treatment in case of bleeding or urgent use the CHMP assessment as part of their surgery. national authorisation process. ►►EMA Press release, 25 September 2015. Newly approved use: Treatment of malaria caused by P. falciparum and P. vivax in children and infants weighing 5 kg to less

Patiromer : for hyperkalaemia ; than 20 kg under 20 kg. Restrictions were Product name: Veltassa® also removed on repeated courses of Dosage form: Powder for oral suspension treatment in patients and on its use only Class: Potassium binder; polymer in areas of low malaria transmission with Approval: FDA evidence of artemisinin resistance. Use: Treatment of hyperkalaemia. Not Note: This artemisinin combination therapy appropriate for rapid correction of severe was first evaluated as film-coated tablets hyperkalaemia because lowering of serum in 2012 and received a positive opinion potassium may take hours to days. under EMA’s Article 58 programme. (1) Benefits: In clinical trials, patiromer was effective in lowering potassium levels in

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Approved

This paediatric antimalarial formulation as Nivolumab: for renal cell cancer well as the film-coated tablet formulation for Product name: Opdivo® adults and children weighing >20kg were Dosage form: Concentrate for solution for developed by the product development infusion partnership Medicines for Malaria Venture Class: Antineoplastic agent, monoclonal (MMV) and Shin Poong Pharmaceutical Co. antibody, PD-1 receptor blocker; Ltd., Republic of Korea. (2) ACT code: L01XC17 ►►(1) EMA/CHMP Summary of opinion, Approval: FDA (breakthrough therapy 19 November 2015. designation, fast track designation, priority (2) MMV Press release, 20 November 2015. review) Newly approved use: Treatment of patients with advanced (metastatic) renal cell Extensions of indications carcinoma who have received prior anti- angiogenic therapy.

Anthrax vaccine adsorbed : for post- ►►FDA News release, 23 November 2015. exposure protection Product name: BioThrax®

Dosage form: Suspension for intramuscular Pembrolizumab: for advanced non-

or subcutaneous injection small cell lung cancer ; Class: Anthrax vaccine; ATC code: J07AC Product name: Keytruda® Approval: FDA Dosage form: For injection: lyophilized Newly approved use: Together with antibiotic powder in single-use vial for reconstitution treatment, to prevent disease after Class: Antineoplastic; PD-1 pathway blocker; confirmed or suspected exposure to ATC code: L01XC18 anthrax spores. Approval: FDA (breakthrough therapy ►►FDA News release, 23 November 2015. designation, accelerated approval). Approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx

Ipilimumab: to prevent melanoma test, the first test designed to detect PD-L1 recurrence expression in non-small cell lung tumours. Product name: Yervoy® Newly approved use: Treatment patients Dosage form: Injection for intravenous with advanced (metastatic) non-small cell infusion lung cancer (NSCLC) whose disease has Class: Antineoplastic, monoclonal antibody progressed after other treatments and that blocks CTLA-4; ATC code: L01XC11 whose tumours express the PD-L1 protein. Approval: FDA Notes: Pembrolizumab was previously Newly approved use: Adjuvant therapy for approved for advanced melanoma by FDA patients with stage III melanoma, to lower and EMA. the risk that the melanoma will return ►►FDA News release, 2 October 2015. following surgery. Safety information: The product carries a Boxed Warning about potential fatal WHO endorsements immune-mediated adverse reactions and unusual severe side effects. Global Ebola virus and antibody ►►FDA News release, 28 October 2015. reference standards The WHO Expert Committee on Biological Standardization has endorsed two types of Ebola reference reagents as the global

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WHO endorsements standards for use in laboratory tests. The (SAGE) and the Malaria Policy Advisory reference reagents were developed within Committee (MPAC) jointly recommended the a short time by the National Institute for implementation of 3–5 large pilot projects Biological Standards and Control (NIBSC) to understand how best to deliver a vaccine and are made available to laboratories that protects against malaria in young around the world through the NIBSC web children. The vaccine must be given in three site (www.nibsc.org/products/brm_product_ doses one month apart, followed by a fourth catalogue.aspx). The first standard is dose 18 months later. The main question is used for testing alongside patient samples how to ensure that each child receives all to detect Ebola infection. The second four doses. measures Ebola antibody levels following The vaccine, known as RTS,S or infection, or following immunization with Mosquirix®, was approved in July 2015 candidate vaccines. by EMA under its Article 58 procedure for The two standards will enable accurate medicines used outside the EU, subject measurement of Ebola virus and antibody, to WHO recommendations on its use. It making it possible to compare results from acts against P. falciparum, the most deadly different tests and different laboratories. By malaria parasite globally and the most minimizing fragmentation and duplication prevalent in Africa. It offers no protection of research efforts these global standards against P. vivax malaria, which predominates will help accelerate the development of new in many countries outside Africa. The Ebola vaccines. vaccine is a complementary tool that could ►►MHRA Press release, 5 November 2015. be added to – but not replace – the core package of proven measures to prevent, diagnose and treat malaria. Malaria vaccine to be delivered in ►►WHO News release, 23 October 2015. æ pilot projects The World Health Organization’s Strategic Advisory Group of Experts on Immunization

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