NNeewwsslleetttteerr Highlights of updates to NDO in November 2015

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in Prescribing Regulatory changes in the EU Outlook 2015

Launched in the UK (Eylea) Visual impairment due to myopic choroidal neovascularisation in adults [licence extension/variation] Aviptadil + phentolamine (Invicorp) Erectile dysfunction in adult men Azacitidine (Vidaza) Acute myeloid leukaemia with more than 30% marrow blasts in patients aged 65 years or older not eligible for stem cell transplant [licence extension/variation] BLI-800 (Eziclen) Bowel cleansing Carfilzomib (Kyprolis) Multiple myeloma in adults – second-line in combination with lenalidomide and Ceftolozane + tazobactam (Zerbaxa) Complicated urinary tract infections in adults / Complicated intra-abdominal

infections and acute pyelonephritis in adults (Xalkori) Advanced non-small cell lung cancer, ALK-positive in adults – first-line [licence extension/variation] Fluticasone propionate + salmeterol Chronic obstructive pulmonary disease in adults [new formulation] xinafoate (AirFluSal Forspiro) Ivacaftor (Kalydeco) Cystic fibrosis in adults who have an R117H mutation and children aged 2 to 5 years with one of nine gating mutations in CTRF gene [licence extension/variation] Leuprorelin (Prostap DCS) Precocious puberty in children [licence extension/variation] Rilpivirine (Edurant) HIV-1 infection in children aged 12 years or older [licence extension/variation] Secukinumab (Cosentyx) Ankylosing spondylitis / Psoriatic arthritis – both second-line in adults [licence extension/variation]

Approved in the EU Blinatumomab (Blincyto) Philadelphia chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukaemia in adults (Cotellic) Unresectable or metastatic melanoma with BRAF V600 mutation in adults – in combination with Efmoroctocog alfa (Elocta) Haemophilia A – treatment and prophylaxis of bleeding in patients of all ages Idarucizumab (Praxbind) Anticoagulation reversal in adults taking dabigatran Isavuconazole (Cresemba) Invasive aspergillosis in adults / Mucormycosis in adults unsuitable for amphotericin B Levodopa + carbidopa ER (Numient) Parkinson’s disease in adults – early-stage / late-stage [new formulation] Methoxyflurane (Penthrox) Emergency relief of moderate-to-severe pain in conscious adults with trauma and

associated pain Rizatriptan (Rizaport) Migraine (not approved in UK) Sacubitril valsartan (Entresto) Symptomatic chronic heart failure with reduced ejection fraction in adults Susoctocog alfa (Obizur) Treatment of bleeding episodes in adults with acquired haemophilia caused by

antibodies to Factor VIII Tenofovir alafenamide + elvitegravir + HIV-1 infection in treatment-naïve patients aged 12 years or older and weighing at cobicistat + emtricitabine (Genvoya) least 35kg [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 November 2015 | 292 monographs updated | 41 evidence-based evaluations added | 5,027 registered NDO users

NNeewwsslleetttteerr

EU positive opinions Brivaracetam (Briviact) Partial-onset seizures – adjunctive therapy in patients aged 16 years and older Certolizumab pegol (Cimzia) Severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate or other DMARDs [licence extension/variation] Etanercept biosimilar – SB4 Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis (Benepali) Pegaspargase (Oncaspar) Acute lymphoblastic leukaemia in adults and children from birth Pitolisant (Wakix) Narcolepsy, with or without cataplexy, in adults

Filed for approval in the EU Abaloparatide Postmenopausal osteoporosis (Alecensa) Non-small cell lung cancer, ALK-positive, after failed crizotinib treatment Anamorelin Anorexia/cachexia associated with non-small cell lung cancer Begelomab (Begedina) Graft versus host disease Chenodeoxycholic acid (Xenbilox) Cerebrotendinous xanthomatosis Empagliflozin + linagliptin (Glyxambi) Type 2 diabetes mellitus [new formulation] Follitropin delta (Rekovelle) Female infertility Ibrutinib (Imbruvica) Chronic lymphocytic leukaemia in newly-diagnosed, treatment-naive patients aged

65 years or older [licence extension/variation] Rituximab biosimilar – CT-P10 Rheumatoid arthritis

Other EU developments Aclerastide Diabetic foot ulcer – development discontinued Encenicline Alzheimer’s disease – development suspended Gevokizumab Uveitis – development discontinued

Phase in Monographs recently added to NDO (14) EU (US)

ALKS8700 Multiple sclerosis None (PI) Anifrolumab Systemic lupus erythematosus PIII (PIII) and ocular hypertension – sustained-release implant PIII (PIII) Cabotegravir HIV infection in treatment-naïve patients – in combination with rilpivirine PII (PII) CXL-1427 Acute decompensated heart failure PII (PII) Dexamethasone Meniere’s disease – intratympanic injection PII (PIII) Fluticasone propionate + salmeterol Asthma in adults and adolescents Launched - PIII UK xinafoate (AirFluSal Forspiro) (None) Idelalisib (Zydelig) Relapsed chronic lymphocytic leukaemia – in combination with PIII (PIII) ofatumumab MRX-I Acute bacterial skin and skin structure infections None (PII) Nitroglycerin (GoNitro) Angina pectoris – acute relief or prophylaxis None (Filed) Pembrolizumab (Keytruda) Colorectal cancer, microsatellite instability high metastatic None (None) Ridinilazole Clostridium difficile infection PII (None) Tavilermide Keratoconjunctivitis sicca (dry eye disease) None (PIII) Voclosporin (Voclera) Lupus nephritis PII (PII)

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In November 2015 | 292 monographs updated | 41 evidence-based evaluations added | 5,027 registered NDO users

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