NNeewwsslleetttteerr Highlights of updates to NDO in January 2013

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in Prescribing Regulatory changes in the EU Outlook 2012

Launched in the UK Abiraterone acetate (Zytiga) Prostate cancer, metastatic, castration-resistant – first-line [licence extension] Darunavir 800mg (Prezista) HIV infection [new strength tablet] Ferumoxytol (Rienso) Iron deficiency anaemia in adults with chronic kidney disease Ingenol mebutate (Picato) Actinic keratosis Nomegestrol acetate + 17 beta Contraception

(Zoely) Saxagliptin + metformin (Komboglyze) Type 2 diabetes mellitus

Approved in the EU Azelastine hydrochloride + fluticasone Allergic rhinitis

propionate (Dymista) Bromelain (NexoBrid) Burns, deep partial and full thickness – removal of eschar Imatinib (Imatinib Teva) Chronic myelogenous leukaemia, Philadelphia chromosome-positive degludec (Tresiba) Type 1 and type 2 diabetes mellitus + (Ryzodeg) Type 1 and type 2 diabetes mellitus Meningococcal group-B vaccine (Bexsero) Meningitis B Mirabegron (Betmiga) Overactive bladder syndrome Pegloticase (Krystexxa) Chronic gout, refractory

EU positive opinions Adalimumab (Humira) Active polyarticular juvenile idiopathic arthritis, in children and adolescents

aged 2 to 17 years [licence extension] Bosutinib (Bosulif) Chronic myeloid leukaemia, Philadelphia chromosome-positive – second- line Canakinumab (Ilaris) Gout, refractory [licence extension] Ocriplasmin (Jetrea) Symptomatic vitreomacular traction, including when associated with a macular hole

Filed for approval in the EU Cabozantinib (Cometriq) Thyroid cancer, medullary Dapagliflozin + metformin Type 2 diabetes mellitus Natalizumab (Tysabri) Multiple sclerosis, relapsing-remitting – first-line [licence extension] Umeclidinium + vilanterol Chronic obstructive pulmonary disease

Other EU developments Cyt002-nicqb Nicotine dependence – development discontinued Dexpramipexole Amyotrophic lateral sclerosis – development discontinued

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 NHS Evidence are included if available at the time of publication Complete monographs are password protected and can be viewed at www.ukmi.nhs.uk/ndo In January 2013 | 220 monographs updated | 27 evidence-based evaluations added | 3,081 registered NDO users

NNeewwsslleetttteerr

Other EU developments (continued) Idebenone (Raxone) Leber's Hereditary Optic Neuropathy [licence extension] – negative opinion Imatinib (Ruvise) Pulmonary hypertension – filing withdrawn Ombrabulin Soft tissue sarcoma – development discontinued

New monographs added (15) Phase in EU

AMG 145 Prevention of cardiac events, in combination with a statin PIII Brentuximab (Adcetris) Peripheral T-cell lymphoma, including CD30-positive mature T-cell PIII lymphoma – first-line Clostridium difficile toxoid vaccine Clostridium difficile infection, prevention of primary symptomatic None infection Duvoglustat Pompe disease PII Factor IX with recombinant albumin Haemophilia B – in children PIII (rIX-FP) Human -related Postmenopausal osteoporosis – transdermal patch PII (None UK) protein analogue Latanoprostene bunod Glaucoma or ocular hypertension PIII MEK162 Malignant melanoma, NRAS mutant PIII Mitoglitazone Type 2 diabetes mellitus None (PII US) PD 0332991 Breast cancer, advanced or metastatic – first-line with letrozole PII Peginterferon beta-1a Multiple sclerosis, relapsing-remitting PIII Tenofovir alafenamide + elvitegravir + HIV infection – in treatment-naïve patients None (PIII US) cobicistat Trastuzumab emtansine Breast cancer, HER2-positive – adjuvant therapy PIII Vemurafenib + GDC-0973 Malignant melanoma – first-line PIII Vilazodone (Viibryd) Generalised anxiety disorder None (PIII US)

Focus: Drugs in development for Phase in EU

Aliskiren (Rasilez) Oral renin inhibitor PIII Autologous stem cell therapy (C-Cure) Intracoronary stem cell therapy PIII Bucindolol (Gencaro) Oral beta-blocker and mild vasodilator None (PIII US) Cell-based heart damage therapy Intracoronary stem cell therapy PIII (MyoCell) Cinaciguat IV soluble guanylate cyclase activator PII Daglutril Oral converting enzyme inhibitor PII LCZ696 Oral angiotensin and neprilysin inhibitor PIII Mydicar IV genetically targeted enzyme replacement therapy intended to restore None (PII US) levels of SERCA2a, a regulator of calcium cycling and contractility Serelaxin IV hormone with cardiorenal function-enhancing properties PIII Ularitide IV synthetic PIII

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In January 2013 | 220 monographs updated | 27 evidence-based evaluations added | 3,081 registered NDO users This is an NHS document not to be used for commercial purposes