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CHMP recommends 19 new medicines for European approval

Praxbind and Entresto - both fast-tracked - among those to be backed

European regulatory advisors at the CHMP backed 19 new medicines for approval last week at the Committee's busiest meeting so far this year.

The Committee for Medicinal Products for Human Use (CHMP) recommended Boehringer Ingelheim's Praxbind (idarucizumab) and Novartis' Entresto (sacubitril/valsartan), both of which have also been fast-tracked under the accelerated assessment procedure.

Praxbind is a reversal agent for Boehringer's Pradaxa (dabigatran) and could give the company a significant boost in the highly competitive market for novel oral anticoagulants.

Novartis' potential blockbuster Entresto is a treatment for symptomatic chronic heart failure with reduced ejection fraction that received early approval in the US over the summer. 

The CHMP also granted Amgen two positive opinions for its myeloma drug Kyprolis and leukaemia drug Blincyto, and recommended Exelis' metastic melanoma drug Cotellic (cobimetinib).

AstraZeneca too scored a double recommendation in type 2 diabetes, with Edistride (dapagliflozin) and Ebymect (dapagliflozin/metformin) backed by the CHMP.

Also recommended were Gilead's Genvoya (elvitegravir/cobicstat/emitricitabine/tenofovir alafenamide), which treats HIV infection, and GlaxoSmithKline's asthma drug Nucala (mpeolizumab).

Vertex Pharmaceuticals' Orkambi (lumacaftor/ivacaftor), a combination treatment for cystic fibrosis, also received a thumbs up, as did Impax's Parkinson's disease treatment Numient (levodopa/carbidopa).

Rounding out the list of branded medicines set for European approval were Incline Thereapeutics' Ionsys (fentanyl) for treating post-operative pain and two orphan drugs: Sobi's haemophilia A treatment Elocta and Horizon Therapeutics' Ravicti (glycerol phenylbutyrate) which is used for urea cycle disorders.

Generic Approvals

Additionally five generic medicines were recommended by the CHMP, including Aripiprazole Accord (aripiprazole) - a version of Lundbeck's schizophrenia and bipolar disorder treatment Abilify.

The remaining four generics are Ciambra, Pemetrexed Hospira and Pemetrexed Medac - all versions of Lilly's mesothelioma and non-small cell lung cancer Alimta (pemetrexed) - and Cinacalet Mylan (cinacalet), a version of Amgen's hyperparathyroidism and parathyroid carcinoma drug Mimpara.

Article by
Nikhil Patel

30th September 2015

From: Regulatory



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