NNeewwsslleetttteerr Highlights of updates to NDO in November 2012 NDO home | Contact | Register for NDO access
in Prescribing Regulatory changes in the EU Outlook 2012 Launched in the UK Adalimumab (Humira) Crohn’s disease, in children – second-line [licence extension] Aminolevulinic acid (Ameluz) Actinic keratosis Apixaban (Eliquis) Stroke prevention in patients with atrial fibrillation [licence extension] Bevacizumab (Avastin) Ovarian, fallopian tube or primary peritoneal cancer, platinum-sensitive, relapsed [licence extension] Brentuximab (Adcetris) Hodgkin’s lymphoma, relapsed or refractory / Systemic anaplastic large cell lymphoma, relapsed or refractory Crizotinib (Xalkori) Non-small cell lung cancer, advanced ALK-positive Dapagliflozin (Forxiga) Type 2 diabetes mellitus – monotherapy and add-on Decitabine (Dacogen) Acute myeloid leukaemia in patients aged 65 years and older Glycopyrronium bromide (Seebri Breezhaler) Chronic obstructive pulmonary disease Rivaroxaban (Xarelto) Pulmonary embolism (PE) – treatment, and prevention of recurrent PE and deep vein thrombosis [licence extension] Approved in the EU Aflibercept (Eylea) Age-related macular degeneration Alipogene tiparvovec (Glybera) Lipoprotein lipase deficiency Everolimus (Votubia) Renal angiomyolipomas associated with tuberous sclerosis complex [licence extension] Ingenol mebutate (Picato) Actinic keratosis Linaclotide (Constella) Irritable bowel syndrome with constipation EU positive opinions Abiraterone acetate (Zytiga) Prostate cancer, metastatic, castration-resistant – first-line [licence extension] Aflibercept (Zaltrap) Colorectal cancer, metastatic – second-line Deferasirox (Exjade) Iron overload, non-transfusion-related in patients with thalassaemia aged 10 years and older [licence extension] Etravirine (Intelence) HIV-1 infection in treatment-experienced children aged six years and older [licence extension] Lixisenatide (Lyxumia) Type 2 diabetes mellitus Meningococcal group-B vaccine (Bexsero) Meningitis B Filed for approval in the EU Anakinra (Kineret) Cryopyrin-associated periodic syndromes [licence extension] Macitentan (Opsumit) Pulmonary hypertension Vintafolide Ovarian cancer, platinum-resistant, folate receptor-positive Other EU developments Algenpantucel-L (HyperAcute Pancreas) Pancreatic cancer – granted orphan drug status Belinostat Peripheral T-cell lymphoma – granted orphan drug status Obinutuzumab Chronic lymphocytic leukaemia – granted orphan drug status Ridaforolimus Soft tissue or bone sarcoma, metastatic – filing withdrawn
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In November 2012 | 300 monographs updated | 42 evidence-based evaluations added | 2,971 registered NDO users
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Other EU developments (continued) Romidepsin (Istodax) Peripheral T-cell lymphoma, relapsed/refractory – second negative opinion Sitagliptin + atorvastatin Type 2 diabetes mellitus and atherosclerosis – development discontinued Taliglucerase alfa (Elelyso) Gaucher’s disease – not approved
New monographs added (18) Phase in EU
Aripiprazole Tourette's disorder in children and adolescents None (PIII US) BAY86-6150 Haemophilia A and B, acute bleeding in patients with neutralising antibody PIII Bile-salt-stimulated lipase, Lipase deficiency in premature infants PIII recombinant human (Kiobrina) Brentuximab (Adcetris) Hodgkin’s lymphoma – first-line, combination therapy PIII Efinaconazole Onychomycosis PIII Fidaxomicin (Dificlir) Clostridium difficile infection, prevention in bone marrow transplant PIII patients Ibrutinib Chronic lymphocytic leukaemia – first-line PIII ISIS-TTRRx Familial amyloid polyneuropathy PII LAS41008 Chronic plaque psoriasis, moderate-to-severe PIII LDK378 Non-small cell lung cancer, ALK-positive – second plus-line PII Nivolumab Malignant melanoma, unresectable or metastatic, first-line / second-line PIII / PIII Orteronel Prostate cancer, castration-resistant, without metastatic disease PII Rivaroxaban (Xarelto) Atherosclerosis, prevention of cardiac events in patients with CAD or PAD PIII Thrombomodulin, recombinant Septic shock None (PIII US) human Tildrakizumab Chronic plaque psoriasis PIII TRx0237 Alzheimer’s disease, mild and moderate PIII Volasertib Acute myeloid leukaemia PIII
Focus: Drugs in development for chronic leukaemias Phase in EU
Chronic lymphocytic leukaemia Alvocidib IV cyclin-dependent kinase inhibitor PIII Bafetinib Oral dual BCR-ABL and Lyn kinase inhibitor PII Dinaciclib IV pro-apoptotic inhibitor of cyclin-dependent kinases None (PIII US) GS-1101 Oral phosphatidylinositol 3-kinase delta inhibitor PIII Ibrutinib Oral selective Bruton’s tyrosine kinase inhibitor – first-line / second-line PIII / PIII Lenalidomide (Revlimid) Oral structural analogue of thalidomide PIII Obinutuzumab IV humanised anti-CD20 monoclonal antibody PIII Ofatumumab (Arzerra) IV human monoclonal antibody – first-line / maintenance after relapse PIII / PIII
Chronic myelogenous leukaemia Bosutinib (Bosulif) Oral dual inhibitor of SRC and ABL kinases Filed Imatinib (Imatinib Teva) Oral small molecule protein-tyrosine kinase inhibitor (biosimilar) Positive opinion Omacetaxine SC first-in-class, reversible, transient inhibitor of protein elongation that PIII mepesuccinate (Omapro) facilitates tumour cell death without depending on BCR-ABL signaling Ponatinib Oral BCR-ABL kinase inhibitor including T315I mutations – first-line / second-line PIII / Filed
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In November 2012 | 300 monographs updated | 42 evidence-based evaluations added | 2,971 registered NDO users
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