NNeewwsslleetttteerr Highlights of updates to NDO in August 2011 NDO home | Contact | Register for NDO access in Prescribing Regulatory changes in the EU Outlook 2010 Launched in the UK Boceprevir (Victrelis) Hepatitis C, chronic genotype 1 – in combination with peginterferon alfa and ribavirin in adults with compensated liver disease Dabigatran etexilate (Pradaxa) Stroke and systemic embolism prevention – in adults with non-valvular atrial fibrillation and other risk factors [licence extension] Denosumab (Xgeva) Bone metastases, in adults with solid tumours – prevention of skeletal- related events Exenatide (Bydureon) Type 2 diabetes mellitus – once-weekly injection Ipilimumab (Yervoy) Malignant melanoma, advanced unresectable or metastatic – second-line Tocilizumab (RoActemra) Systemic juvenile idiopathic arthritis [licence extension] Approved in the EU Digoxin immune Fab (DigiFab) Digoxin toxicity [currently approved in UK but no other EU countries] Linagliptin (Trajenta) Type 2 diabetes mellitus EU positive opinions Esomeprazole + aspirin Cardiovascular (CV) event prevention – in high-risk CV patients at risk of (Axanum) gastric ulcers Mercaptopurine oral suspension Acute lymphoblastic leukaemia Filed for approval in the EU Aclidinium bromide (Eklira Chronic obstructive pulmonary disease Genuair) Alprostadil (Vitaros) Erectile dysfunction – topical preparation Bosutinib Chronic myeloid leukaemia, newly diagnosed Philadelphia chromosome- positive Crizotinib (Xalkori) Non-small cell lung cancer, advanced ALK-positive Decitabine (Dacogen) Acute myeloid leukaemia Mirabegron Overactive bladder Ridaforolimus Soft tissue or bone sarcoma, metastatic Other EU developments Cediranib (Recentin) Non-small cell lung cancer – development discontinued Macitentan Pulmonary hypertension – recommended for orphan drug status Pyridoxalated haemoglobin Septic shock, catecholamine-resistant – development discontinued polyoxyethylene (Hemoximer) Telcagepant Migraine – development discontinued Zibotentan Prostate cancer, metastatic hormone-refractory – development discontinued New monographs added (29) Phase in EU Adalimumab (Humira) Axial spondyloarthritis PIII Alprostadil (Vitaros) Erectile dysfunction – topical preparation Filed Anamorelin HCl Cancer cachexia PIII 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 August 2011 | 363 monographs updated | 135 evidence-based evaluations added | 2,168 registered NDO users Newsletter New monographs added (continued) Phase in EU ASP0113 (TransVax) Cytomegalovirus infections, reactivation in haematopoietic stem cell PII transplant Bevacizumab (Avastin) Breast cancer, triple negative disease – adjuvant therapy / Colon PIII / PIII cancer, metastatic – second plus-line Botulinum toxin A (Botox) Urinary frequency, urgency and incontinence – in adults with neurogenic Approved bladder due to spinal cord injury or multiple sclerosis (PIII UK) Colistin (Colobreathe) Cystic fibrosis Filed Dovitinib Renal cell carcinoma, metastatic – third-line PIII Ecallantide (Kalbitor) Angioedema, ACE inhibitor-induced PII (None UK) Empagliflozin + linagliptin Type 2 diabetes mellitus PIII Eribulin (Halaven) Breast cancer, locally advanced or metastatic – second-line PIII Eslicarbazepine (Zebinix) Epilepsy, partial onset seizures – monotherapy PIII (None UK) Etanercept (Enbrel) Juvenile idiopathic arthritis, oligoarticular, enthesitis-related or psoriatic PIII Everolimus (Afinitor) Breast cancer, early – neoadjuvant therapy PIII (PII UK) Exenatide (Byetta) Type 2 diabetes mellitus – third-line in combination with insulin PIII Gabapentin enacarbil (Solzira) Postherpetic neuralgia PII (None UK) Insulin glargine (Lantus) Type 1 and 2 diabetes mellitus PIII Lebrikizumab Asthma PII Letermovir Cytomegalovirus infections PII Liraglutide (Victoza) Type 2 diabetes mellitus – third-line in combination with basal insulin PIII Masitinib Rheumatoid arthritis PIII (None UK) Octreolin Acromegaly PIII Ponesimod Multiple sclerosis, relapsing-remitting PII Secukinumab Psoriatic arthritis PIII Sorafenib (Nexavar) Non-small cell lung cancer, non squamous – third plus-line PIII Strontium ranelate (Protelos) Osteoporosis, male PIII Trastuzumab (Herceptin) Breast cancer, HER2-positive – subcutaneous formulation PIII Treprostinil diethanolamine Pulmonary hypertension PIII Focus: Drugs in development for constipation and diarrhoea Phase in EU Constipation Linaclotide Oral guanylase cyclate stimulant None (Filed US) Plecanatide Oral uroguanylin analogue PII Prucalopride (Resolor) Oral selective, high-affinity 5-HT4 receptor agonist with enterokinetic PIII activity [licence extension for use in men] Diarrhoea Crofelemer (Provir) Oral oligomeric proanthocyanidin [in HIV/AIDS / in irritable bowel None (PIII US) / syndrome] None (PII US) Prulifloxacin (Pruvel) Oral fluoroquinolone [in traveller’s diarrhoea] None (PIII US) Rifaximin (Xifaxanta) Oral RNA synthesis inhibitor [in irritable bowel syndrome / in traveller’s None / Launched diarrhoea] (Approved UK) Traveler’s diarrhoea vaccine Topical vaccine patch Discontinued If you do not wish to continue receiving NDO Newsletter log in and update your profile at www.ukmi.nhs.uk/ndo In August 2011 | 363 monographs updated | 135 evidence-based evaluations added | 2,168 registered NDO users .