NNeewwsslleetttteerr Highlights of updates to NDO in March 2015

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in Prescribing Regulatory changes in the EU Outlook 2014

Launched in the UK Apremilast (Otezla) Chronic plaque psoriasis in adults / Psoriatic arthritis in adults – both second-line Bromelain (NexoBrid) Removal of eschar in adults with deep partial- and full-thickness thermal burns biosimilar (Accofil) Neutropenia Follicle stimulating hormone In vitro fertilisation biosimilar (Bemfola) Paclitaxel albumin-bound Advanced non-small cell lung cancer – first-line in combination with carboplatin in (Abraxane) adults unsuitable for surgery or radiation therapy [licence extension/variation] (Jakavi) Polycythemia vera in adults resistant to or intolerant of hydroxyurea [licence extension/variation]

Approved in the EU Atorvastatin + ezetimibe (Atozet) Hypercholesterolaemia [new formulation] Ciclosporin (Ikervis) Severe keratitis in adults with dry eye disease [new formulation] Dalbavancin (Zydalba) Acute bacterial skin and skin structure infections in adults Ivermectin (Soolantra) Papulopustular rosacea in adults [new formulation] Naltrexone + bupropion Weight management in adults who are obese, or those who are overweight and (Mysimba) have one or more complications related to their weight [new formulation] Tilmanocept (Lymphoseek) Imaging and intraoperative mapping of lymphatic tissue in patients with breast cancer, melanoma or localised squamous cell carcinoma of the oral cavity Tobramycin (Vantobra) Chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged six years and older with cystic fibrosis (second positive opinion) [new formulation]

EU positive opinions Empagliflozin + metformin Type 2 diabetes mellitus in adults – second-line [new formulation]

(Synjardy) Human papillomavirus vaccine Active immunisation of individuals from the age of 9 years against premalignant (9-valent) (Gardasil 9) lesions and cancers affecting the cervix, vulva, vagina and anus, and genital warts, caused by human papillomavirus types [new formulation] (Lenvima) Thyroid cancer, differentiated, radioiodine-refractory in adults Netupitant + palonosetron Prevention of chemotherapy-induced nausea and vomiting [new formulation]

(Akynzeo) Tafluprost + timolol (Taptiqom) Open angle glaucoma or ocular hypertension [new formulation]

Filed for approval in the EU (Eylea) Myopic choroidal neovascularisation of the retina [licence extension/variation] Amikacin liposomal (Arikace) Pseudomonas aeruginosa infection in patients with cystic fibrosis [new formulation] Betamethasone dipropionate + Chronic plaque psoriasis [new formulation]

calcipotriol (Enstilar) Capsaicin patch (Qutenza) Peripheral diabetic neuropathy [licence extension/variation] (Xalkori) Advanced non-small cell lung cancer, ALK-positive – first-line [licence extension/variation]

To access New Drugs Online monographs click on the drug name/indication or visit www.ukmi.nhs.uk/ndo

Direct links to abbreviated NDO monographs via NICE Evidence Search are included Complete monographs are password protected and can be viewed at www.ukmi.nhs.uk/ndo In March 2015 | 1,581 monographs updated | 34 evidence-based evaluations added | 4,572 registered NDO users

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Filed for approval in the EU (continued) Daclizumab (Zinbryta) Relapsing-remitting multiple sclerosis (Afinitor) Advanced breast cancer, HER2-positive disease – second or third-line with and vinorelbine [licence extension/variation] Golimumab (Simponi) Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis – second-line [licence extension/variation] House dust allergy vaccine (Mitizax) Allergic rhinitis and allergic asthma (Imbruvica) Waldenström’s macroglobulinemia [licence extension/variation] Idarucizumab Anticoagulation reversal in patients taking dabigatran Infliximab biosimilar – SB2 Rheumatoid arthritis subcutaneous (MabThera) Chronic lymphocytic leukaemia – first-line [licence extension/variation] Sirolimus Non-infectious uveitis of the posterior segment [new formulation] Tipiracil + trifluridine (Lonsurf) Metastatic colorectal cancer in adults – second-line

Other EU developments Abagovomab Ovarian cancer – development discontinued Alvocidib Acute myeloid leukaemia – granted orphan drug status Apixaban (Eliquis) Prevention of venous thromboembolism in medically-ill patients – development

discontinued (Inlyta) Breast cancer / Liver cancer – development discontinued

BI-505 Smouldering multiple myeloma – development discontinued

Bitopertin Schizophrenia – development discontinued

Ceritinib (Zykadia) Non-small cell lung cancer – awarded Promising Innovative Medicine status

Darapladib Acute coronary syndrome – development discontinued

Darbepoetin alfa (Aranesp) Anaemia associated with heart failure – development discontinued

Enobosarm (Ostarine) Cancer cachexia in non-small cell lung cancer – development discontinued

Eribulin (Halaven) Advanced non-small cell lung cancer – development discontinued Everolimus (Afinitor) Advanced breast cancer, HER2-positive disease, first-line with trastuzumab and paclitaxel – development discontinued Fingolimod (Gilenya) Primary-progressive multiple sclerosis – development discontinued FBS0701 Iron overload after chronic transfusion – trials suspended Glycopyrronium bromide (Seebri Asthma, poorly controlled – development discontinued

Breezhaler) Inclacumab Peripheral vascular disease – development discontinued Ketamine (Ereska) Pain – development discontinued Morphine + oxycodone (MoxDuo IR) Moderate-to severe pain – development discontinued (Arzerra) Diffuse large B-cell lymphoma – development discontinued Pembrolizumab (Keytruda) Advanced malignant melanoma – granted Promising Innovative Medicine status Quizartinib Acute myeloid leukaemia – granted orphan drug status

Phase in Monographs recently added to NDO (26) EU (US)

Algenpantucel-L (HyperAcute Pancreatic cancer – adjuvant combination therapy in patients who have None (PIII) Pancreas) undergone surgical resection AMG-337 MET-amplified gastric, gastro-oesophageal junction or oesophageal PII (PII) adenocarcinoma

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In March 2015 | 1,581 monographs updated | 34 evidence-based evaluations added | 4,572 registered NDO users

This is an NHS document not to be used for commercial purposes

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Phase in Monographs recently added to NDO (continued) EU (US)

ARN-509 Metastatic prostate cancer, castration-resistant – in chemotherapy-naïve men PIII (PIII) biosimilar – ABP 494 Colorectal cancer, and head and neck cancer None (Pre-clinical) CT327 Psoriasis-associated pruritus PII (PII) Emricasan Non-alcoholic fatty liver disease including non-alcoholic steatohepatitis None (PII) Factor VIIa, recombinant Haemophila A and B in patients with inhibitors to factor VIII or factor IX PIII (PIII) Fluticasone furoate + salmeterol Asthma in adults and adolescents and COPD in adults Launched (None) xinafoate (AirFluSal) GS-9857 Hepatitis C infection – in combination with sofosbuvir plus velpatasvir None (PII) Infliximab biosimilar – ABP 710 Rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, None Crohn’s disease and ulcerative colitis (Pre-clinical) Levetiracetam Alzheimer’s disease PII (PII) Lopixibat Alagille Syndrome in paediatric patients PII (PII) Osilodrostat Cushing’s disease PIII (PIII) Pretomanid Tuberculosis None (None) Revusiran Familial amyloid cardiomyopathy PIII (PIII) Rituximab biosimilar – ABP 798 Non-Hodgkin’s lymphoma PIII (None) Rituximab biosimilar – MabionCD20 Large B-cell lymphoma, CD20-positive / Rheumatoid arthritis PIII / PIII (None / None) Rituximab biosimilar – MK8808 Follicular lymphoma, CD20-positive / Rheumatoid arthritis PIII / PI (None / PI) Romosozumab Osteoporosis in men PIII (PIII) Ropeginterferon alfa-2b Polycythaemia vera – first-line PIII (PIII) Somatropin Growth hormone deficiency in adults – long-acting formulation PIII (PIII) Veliparib Brain metastases from non-small cell lung cancer PII (PII) (Zelboraf) Brain metastases in patients with melanoma / Metastatic malignant melanoma, PII (PII) / PI (PI) BRAFV600 mutation positive in paediatric patients

Focus: Drugs in development for macular or retinal disorders Phase in EU

Aflibercept (Eylea) Intravitreal VEGF inhibitor – diabetic retinopathy in patients with diabetic PIII / Filed macular oedema (DMO) / Myopic choroidal neovascularisation biosimilar – BCD-021 Intravitreal VEGF inhibitor None Pegpleranib (Fovista) Intravitreal platelet-derived -B inhibitor PIII Emixustat Oral non-retinoid RPE65 enzyme inhibitor None (PIII US) Fenretinide Oral vitamin A binding protein antagonist PII NT-501 Intraocular implant containing human cells genetically modified to secrete PII ciliary neurotrophic factor (Lucentis) Intravitreal VEGF inhibitor – choroidal neovascularisation and macular PIII oedema, not due to macular degeneration, DMO or RVO Squalamine (Evizon) Intravenous and topical VEGF and platelet-derived growth factor inhibitor None (PII US) Unoprostone isopropyl Topical prostaglandin F2 alpha agonist None

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In March 2015 | 1,581 monographs updated | 34 evidence-based evaluations added | 4,572 registered NDO users

This is an NHS document not to be used for commercial purposes