NNeewwsslleetttteerr Highlights of updates to NDO in February 2016 NDO home | Contact | Register for NDO access in Prescribing Regulatory changes in the EU Outlook 2015 Launched in the UK Brivaracetam (Briviact) Partial-onset seizures – adjunctive therapy in patients aged 16 years and older Etanercept biosimilar – SB4 Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis (Benepali) Ezetimibe (Ezetrol) Cardiovascular event risk reduction in patients with coronary heart disease and history of acute coronary syndrome – in combination with a statin [licence extension/variation] Ezetimibe + simvastatin (Inegy) Cardiovascular event risk reduction of risk of in patients with coronary heart disease and history of acute coronary syndrome either previously treated with a statin or not [licence extension/variation] Guanfacine (Intuniv) Attention-deficit hyperactivity disorder in patients aged six to 17 years Nitisinone (Orfadin) Hereditary tyrosinaemia type-1 [new oral suspension and 20mg capsule] Panobinostat (Farydak) Multiple myeloma, relapsed and/or refractory in adults who have received at least two prior regimens including bortezomib and an immunomodulatory agent – in combination with bortezomib and dexamethasone Ramucirumab (Cyramza) Metastatic colorectal cancer in adults – second-line in combination with FOLFIRI [licence extension/variation] Ramucirumab (Cyramza) Locally advanced or metastatic non-small cell lung cancer in adults – second-line in combination with docetaxel [licence extension/variation] Approved in the EU Lesinurad (Zurampic) Hyperuricaemia in adults with gout (with or without tophi) – second-line adjunctive treatment in combination with a xanthine oxidase inhibitor Necitumumab (Portrazza) Advanced squamous, EGFR-positive non-small cell lung cancer in adults – first-line in combination with gemcitabine and cisplatin Nicotine (e-Voke) Smoking cessation – electronic inhaler [new formulation] Nicotine (Voke) Smoking cessation – inhaler [new formulation] Octocog alfa sucrose plasma Treatment and prophylaxis of bleeding in patients with haemophilia A [new formulation] protein-free (Iblias) Osimertinib (Tagrisso) Advanced non-small cell lung cancer, EGFR T790M-positive Ticagrelor (Brilique) Prevention of atherothrombotic events in adults with previous myocardial infarction, at high risk of developing an atherothrombotic event [new 60mg tablet formulation] EU positive opinions Adalimumab (Humira) Moderate-to-severe chronic plaque psoriasis in adults who are candidates for systemic therapy [licence extension/variation] Afatinib (Giotrif) Advanced squamous non-small cell lung cancer progressing on or after platinum-based chemotherapy – monotherapy [licence extension/variation] Albutrepenonacog alfa (Idelvion) Treatment and prophylaxis of bleeding in adults and adolescents or children with haemophilia B [new formulation] Conestat alfa (Ruconest) Treatment of acute angioedema attacks in adolescents with hereditary angioedema due to C1 esterase inhibitor deficiency [licence extension/variation] Eftrenonacog alfa (Alprolix) Treatment and prophylaxis of bleeding in patients with haemophilia B [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 2016 | 406 monographs updated | 232 evidence-based evaluations added | 5,231 registered NDO users NNeewwsslleetttteerr EU positive opinions (continued) Emtricitabine + tenofovir HIV-1 infection in adults and adolescents aged 12 years and older with body weight at alafenamide (Descovy) least 35 kg – in combination with other antiretroviral agents [new formulation] Idelalisib (Zydelig) Use in combination with ofatumumab for adults with chronic lymphocytic leukaemia who have received at least one prior therapy, or first-line in the presence of 17p deletion or TP53 mutation [licence extension/variation] Ixekizumab (Taltz) Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy Nivolumab (Opdivo) Advanced non-squamous non-small cell lung cancer after prior chemotherapy in adults [licence extension/variation] Nivolumab (Opdivo) Advanced renal cell carcinoma after prior therapy in adults – monotherapy [licence extension/variation] Trifluridine + tipiracil (Lonsurf) Metastatic colorectal cancer in adults who have been previously treated with, or are not considered candidates for, available therapies. Filed for approval in the EU Levonorgestrel Contraception for up to five years [new intrauterine formulation] Prasterone (Vaginorm) Vulvovaginal or vaginal atrophy Tenofovir alafenamide Chronic hepatitis B infection in adults Other EU developments Acalabrutinib Chronic lymphocytic leukaemia – granted orphan drug status Amikacin liposomal (Arikayce) Pseudomonas aeruginosa pulmonary infections in patients with cystic fibrosis – filing withdrawn Bavituximab (Tarvacin) Advanced HER2-negative breast cancer – development suspended Bavituximab (Tarvacin) Non-squamous non-small cell lung cancer – development discontinued Nivolumab (Opdivo) Advanced non-squamous non-small cell lung cancer after prior chemotherapy in adults whose tumours express programmed death ligand-1 – granted Early Access to Medicines Scheme status in the UK Nivolumab (Opdivo) Advanced renal cell carcinoma after prior therapy in adults – granted Early Access to Medicines Scheme status in the UK Pyridoxamine (Pyridorin) Diabetic nephropathy – development suspended Ruxolitinib (Jakavi) Pancreatic cancer – development discontinued Phase in Monographs recently added to NDO (23) EU (US) Acalabrutinib Chronic lymphocytic leukaemia PII (PIII) Adalimumab biosimilar – FKB-327 Rheumatoid arthritis PIII (PIII) Albutropin Growth hormone deficiency in adults PIII (PIII) Bevacizumab biosimilar – FKB-238 Cancer PI (None) Buprenorphine Opioid dependence – subcutaneous depot PIII (None) Ceftaroline (Zinforo) Skin and skin structure infections in children PIII (Filed) Fibrinogen concentrate (human) Prevention of intraoperative bleeding in patients with congenital fibrinogen Approved (None) (FibCLOT) deficiency Furosemide (Sc2Wear) Chronic heart failure in patients with oedema – micropump patch PII (PIII) Hexaminolevulinate hydrochloride Biopsy-confirmed cervical high-grade squamous intraepithelial lesions in PII (PII) (Cevira) adults Hydrocortisone (Chronocort) Congenital adrenal hyperplasia in adults – extended-release formulation None (PII) Hydrocortisone (Infacort) Congenital adrenal hyperplasia in children aged less than six years old PIII (None) If you do not wish to continue receiving NDO Newsletter log in and update your profile at www.ukmi.nhs.uk/ndo In February 2016 | 406 monographs updated | 232 evidence-based evaluations added | 5,231 registered NDO users This is an NHS document not to be used for commercial purposes NNeewwsslleetttteerr Phase in Monographs recently added to NDO (continued) EU (US) Lusutrombopag (Mulpleta) Thrombocytopenia in adults with chronic liver disease prior to elective invasive PIII (PIII) procedures Masitinib Relapsed or refractory peripheral T-cell lymphoma PIII (None) Metformin Polycystic ovary syndrome – effervescent oral solution PIII (None) Olaparib (Lynparza) Metastatic castration-resistant prostate cancer, BRCA 1/2 or ATM gene-mutated PII (PII) Oliceridine Acute moderate-to-severe pain None (PIII) OSE-2101 (Tedopi) Locally advanced or metastatic non-small cell lung cancer, HLA-A2-positive PIII (PIII) Pelareorep (Reolysin) Relapsed or refractory multiple myeloma None (PI) Sacituzumab govitecan Relapsed or refractory triple-negative breast cancer PIII (PIII) Secnidazole Bacterial vaginosis in adolescent and adult women None (PII) Veliparib Locally advanced or metastatic unresectable breast cancer, HER2-negative, PIII (PIII) BRCA-associated – in combination with carboplatin and paclitaxel Venetoclax Acute myeloid leukaemia in patients unfit for intensive chemotherapy PII (PII) Zoledronic acid + prednisolone Osteoarthritis None (None) Focus: Drugs in development for Alzheimer’s disease Phase in EU Aducanumab IV gamma-1 monoclonal antibody PIII AZD3293 Oral beta secretase cleaving enzyme inhibitor PIII Bapineuzumab SC amyloid-beta monoclonal antibody None Eltroprazine Oral 5-HT1a/1b partial agonist None Encenicline Oral nicotinic alpha-7 agonist Suspended Flutemetamol (Vizamyl) IV positron-emission tomography enhancer imaging agent Launched (not UK) Gantenerumab SC amyloid-beta monoclonal antibody – early-stage / mild disease PIII / PIII Idalopirdine Oral selective 5-HT6 antagonist PIII Ispronicline Oral selective partial agonist of α4β2 subtype of neuronal nicotinic receptors Discontinued Leuco-methylthioninium Oral second‐generation tau aggregation inhibitor PIII Levetiracetam Oral acetylcholine agonist PII Liraglutide (Victoza) SC glucagon-like peptide-1 analogue None (PII UK) Masitinib Oral tyrosine kinase inhibitor PIII Nilvadipine Oral calcium channel blocker PIII Pioglitazone (Actos) Oral peroxisome proliferator-activated receptor-gamma agonist PIII RVT-101 Oral 5-HT6 antagonist PIII Scyllo-inositol Oral amyloid-beta aggregation inhibitor PII Solanezumab IV amyloid-beta monoclonal antibody – early-stage / mild-to-moderate disease PIII / PIII Verubecestat Oral amyloid-beta precursor protein site-cleaving enzyme inhibitor – early- PIII / PIII stage / mild-to-moderate disease Focus: Drugs in development for other dementias Phase in EU Leuco-methylthioninium Oral second‐generation tau aggregation inhibitor PIII NAV4694 IV fluorine-18 labelled radiopharmaceutical None If you do not wish to continue receiving NDO Newsletter log in and update your profile at www.ukmi.nhs.uk/ndo In February 2016 | 406 monographs updated | 232 evidence-based evaluations added | 5,231 registered NDO users This is an NHS document not to be used for commercial purposes .