NNeewwsslleetttteerr Highlights of updates to NDO in February 2014
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in Prescribing Regulatory changes in the EU Outlook 2013
Launched in the UK Botulinum toxin A (Botox) Stroke-associated ankle disability [licence extension] Canagliflozin (Invokana) Type 2 diabetes mellitus in adults Cobicistat (Tybost) HIV infection in adults Dimethyl fumarate (Tecfidera) Multiple sclerosis, relapsing-remitting Dolutegravir (Tivicay) HIV infection in adults and adolescents from age 12 years Elvitegravir (Vitekta) HIV infection in adults Lipegfilgrastim (Lonquex) Chemotherapy-induced neutropenia Sofosbuvir (Sovaldi) Hepatitis C infection in adults Solifenacin + tamsulosin (Vesomni) Benign prostatic hyperplasia-associated lower urinary tract symptoms [new
formulation] Ulipristal (Esmya) Uterine fibroids – repeat three-month treatment course after previous pre-operative
treatment of moderate to severe symptoms [licence extension]
Approved in the EU Autologous cultured chondrocytes Full-thickness cartilage defects of the knee in adults (MACI) Brimonidine (Mirvaso) Rosacea facial erythema in adults [new formulation] Ethinylestradiol + gestodene Contraception [transdermal formulation] Somatropin Growth hormone deficiency [once-weekly formulation]
EU positive opinions Budesonide + formoterol (DuoResp Asthma and chronic obstructive pulmonary disease [new formulation] Spiromax) Canagliflozin + metformin IR Type 2 diabetes mellitus (Vokanamet) Elosulfase alfa (Vimizim) Mucopolysaccharidosis IVA (Morquio syndrome) Follicle stimulating hormone In vitro fertilisation biosimilar (Bemfola) Propranolol (Hemangiol) Proliferating infantile haemangioma [new formulation] Rituximab (MabThera) Non-Hodgkin's lymphoma [subcutaneous formulation] Umeclidinium (Incruse) Chronic obstructive pulmonary disease Umeclidinium + vilanterol (Anoro) Chronic obstructive pulmonary disease
Filed for approval in the EU Apixaban (Eliquis) Treatment of deep vein thrombosis and pulmonary embolism, and prevention of their recurrence [licence extension] Cangrelor Prevention of thrombosis in patients undergoing CABG Ciclosporin (Restasis) Keratoconjunctivitis sicca, moderate-to-severe [new formulation]
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 February 2014 | 576 monographs updated | 34 evidence-based evaluations added | 3,797 registered NDO users
Newsletter Newsletter
Filed for approval in the EU (continued) Dinutuximab (Unituxin) Neuroblastoma in children Indacaterol + glycopyrronium bromide Asthma [licence extension]
(Ultibro Breezhaler) Levofloxacin (Aeroquin) Cystic fibrosis-associated Pseudomonas aeruginosa infection [new formulation] Liraglutide (Victoza) Type 2 diabetes mellitus – in combination with basal insulin [licence extension] Lisdexamfetamine dimesylate (Elvanse) Attention-deficit hyperactivity disorder, newly-diagnosed in adults [licence
extension] Netupitant + palonosetron Chemotherapy-induced nausea and vomiting [new formulation] Oritavancin (Nuvocid) Complicated bacterial skin and skin structure infections Sofosbuvir + ledipasvir Chronic hepatitis C virus genotype 1 infection in adults [new formulation] Tedizolid phosphate Acute bacterial skin and skin structure infections
Other EU developments Amikacin liposomal (Arikace) Nontuberculous mycobacterial lung disease – issued a positive opinion for
orphan drug status Ataluren (Translarna) Duchenne muscular dystrophy – company requests re-examination of negative opinion Eculizumab (Soliris) Prevention of delayed graft function after solid organ transplantation – granted
orphan drug status
Hepatitis B vaccine (Heplisav) Hepatitis B – filing withdrawn
Icatibant (Firazyr) ACE inhibitor-induced angioedema – filing withdrawn Masitinib (Masiviera) Pancreatic cancer, advanced – company requests re-examination of negative opinion Ridaforolimus (Jenzyl) Breast cancer / Endometrial cancer / Prostate cancer / Soft tissue and bone sarcoma – development discontinued Sofosbuvir + ledipasvir Chronic hepatitis C virus genotype 1 infection in adults – opinion on a compassionate use programme announced
Tanezumab Osteoarthritis – development suspended
New monographs added (27) Phase in EU
Afuresertib Multiple myeloma – combination therapy None (PII US) Bevacizumab biosimilar – ABP 215 Non-small cell lung cancer, advanced PIII c1 inhibitor (human) (Cinryze) Hereditary angioedema – prophylaxis in children aged 6 to 11 PIII Delafloxacin Uncomplicated urogenital gonorrhoea None (PIII US) EBI-005 Dry eye None (PIII US) EMA401 Postherpetic neuralgia None Evolocumab Homozygous familial hypercholesterolaemia PIII Febuxostat (Adenuric) Tumour lysis syndrome PII Gantenerumab Alzheimer’s disease, mild PIII Ibodutant Irritable bowel syndrome, diarrhoea-predominant PII Insulin glargine biosimilar – MK-1293 Type 1 and type 2 diabetes mellitus PIII IPI-145 Chronic lymphocytic leukaemia or small cell lymphoma, refractory PIII or relapsed
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In February 2014 | 576 monographs updated | 34 evidence-based evaluations added | 3,797 registered NDO users This is an NHS document not to be used for commercial purposes
Newsletter Newsletter
New monographs added (continued) Phase in EU
ISIS-SMNRx Spinal muscular atrophy PII Losmapimod Acute coronary syndrome PII Lubiprostone (Amitiza) Irritable bowel syndrome, constipation-predominant, in women None (Launched US) Masitinib Prostate cancer, metastatic, castrate-resistant – first-line PIII combination therapy Mepolizumab Eosinophilic granulomatosis with polyangiitis PIII Mercaptamine bitartrate Huntington's disease PIII Muscle derived cells-urethral sphincter Stress incontinence PIII repair Nivolumab Non-small cell lung cancer, stage IV or recurrent PD-L1 – first-line PIII OMS824 Huntington’s disease PII Palbociclib Breast cancer in patients at high risk of recurrence post- PIII neoadjuvant therapy PBT2 Huntington's disease None (PII US) Ragweed allergy therapy (Ragwitek) Allergic rhinitis None (Positive opinion US) Ramucirumab (Cyramza) Colorectal cancer – second-line combination therapy PIII Ramucirumab (Cyramza) Non-small cell lung cancer – second-line combination therapy PIII Recombinant human antithrombin iii Pre-eclampsia None (PIII US) (ATryn)
Focus: Drugs in development for lung cancer Phase in EU
Non-small cell lung cancer Afatinib (Giotrif) Oral dual EGFR and HER2 inhibitor – second-line in squamous disease PIII / / third or fourth-line Suspended Alectinib Oral ALK inhibitor PII Apricoxib (Capoxigem) Oral selective COX-2 inhibitor PII Astuprotimut-R IM oncology vaccine PIII Bavituximab IV angiogenesis inhibitor PIII Belagenpumatucel-L (Lucanix) Intradermal antisense-DNA vaccine PIII Belinostat Oral HDAC inhibitor PII Bevacizumab (Avastin) IV VEGF antagonist – adjuvant therapy PIII Bevacizumab biosimilar – ABP 215 IV VEGF antagonist PIII Ceritinib Oral ALK inhibitor – first-line / second plus-line PIII / PIII Cisplatin liposomal (Nanoplatin) IV formulation that delivers cisplatin directly into cancer cells PIII Custirsen IV clusterin inhibitor and antisense oligonucleotide PIII Dabrafenib (Tafinlar) Oral BRAF inhibitor PII Dacomitinib Oral pan-HER inhibitor – first-line / second-line PIII / PIII Dimesna (Tavocept) IV antioxidant PIII Entinostat Oral histone deacetylase inhibitor PII
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In February 2014 | 576 monographs updated | 34 evidence-based evaluations added | 3,797 registered NDO users This is an NHS document not to be used for commercial purposes
Newsletter Newsletter
Focus: Drugs in development for lung cancer Phase in EU
Non-small cell lung cancer (continued) Erlotinib (Tarceva) Oral EGFR inhibitor – adjuvant therapy / maintenance treatment PIII / Filed Fosbretabulin (Zybrestat) IV cadherin 5 inhibitor PII Ganetespib IV heat shock protein 90 inhibitor PIII Gefitinib (Iressa) Oral EGFR inhibitor – second-line after first-line gefitinib PIII Ipilimumab (Yervoy) IV human antibody against CTLA-4 PIII Lambrolizumab IV humanised monoclonal IgG4 antibody against PD-1 protein PIII MPDL3280A IV immunotherapy involving PD-L1 protein PIII Necitumumab IV EGFR antagonist – non-squamous / squamous PIII / PIII Nimotuzumab (Theraloc) IV EGFR-targeting monoclonal antibody None (PII US) Nintedanib (Vargatef) Oral VEGFR-2, fibroblast growth factor receptor and platelet-derived Filed growth factor receptor inhibitor Nivolumab IV PDCD 1 inhibitor – first-line / second-line PIII / PIII Onartuzumab IV monovalent 5D5 anti-c-Met monoclonal antibody PIII Paclitaxel albumin-bound (Abraxane) IV tubulin inhibitor – first-line / maintenance PIII / None (PIII US) Pralatrexate (Folotyn) IV apoptosis stimulant, dihydrofolate reductase inhibitor and DNA PII synthesis inhibitor Ramucirumab (Cyramza) IV VEGFR-2 antagonist PIII Selumetinib Oral selective and uncompetitive MEK kinase inhibitor PIII Talactoferrin alfa Oral dendritic cell recruiter and activator PIII Tecemotide (Stimuvax) SC cancer vaccine – induces a specific immune response to MUC-1 PIII Tergenpumatucel-L (HyperAcute Lung) Intradermal immunotherapy None (PIII US) Tertomotide Intradermal telomerase vaccine None (PIII US) TG4010 SC therapeutic vaccine PIII Vinflunine (Javlor) IV vinca-alkaloid microtubule inhibitor PIII
Small cell lung cancer Amrubicin (Calsed) IV topoisomerase II inhibitor Unknown Ipilimumab (Yervoy) IV human antibody against CTLA-4 PIII Palifosfamide (Zymafos) IV alkylating agent PII Reovirus (Reolysin) IV immunomodulator None (PII US)
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In February 2014 | 576 monographs updated | 34 evidence-based evaluations added | 3,797 registered NDO users This is an NHS document not to be used for commercial purposes