Nineteen New Medicines Backed for European Approval
Nineteen new therapies, which include an antidote to the blood thinner Pradaxa, a treatment for the rare blood cancer multiple myeloma, and a new drug for Parkinson’s disease. Have taken a leap closer to being granted entry to the EU market.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has endorsed approval for:
+ Boehringer Ingelheim’s Praxbind (idarucizumab) as a specific antidote to the anticoagulant medicine Pradaxa (dabigatran etexilate), when rapid reversal is required
+ Novartis’ Entresto (sacubitril/valsartan) for the treatment of symptomatic chronic heart failure with reduced ejection fraction
+ Amgen’s Kyprolis (carfilzomib) for multiple myeloma patients whose disease has relapsed after receiving at least one prior course of therapy
+ Amgen’s Blincyto (blinatumomab) for the treatment of Philadelphia chromosome-negative acute lymphoblastic leukaemia (under a conditional marketing approval)
+ Roche’s Cotellic (cobimetinib) for the treatment of metastatic melanoma
+ Gilead’s Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) to treat HIV infection
+ GlaxoSmithKline’s Nucala (mepolizumab) for the treatment of asthma
+ Vertex’ Orkambi (lumacaftor/ivacaftor) for cystic fibrosis
+ Impax Labs’ Numient (levodopa/carbidopa) for the treatment of Parkinson’s disease
+ Incline Therapeutics’ Ionsys (fentanyl) for post-operative pain
+ Biogen Idec’s Elocta (efmoroctocog alfa) for haemophilia A
+ Horizon Therapeutics’ Ravicti (glycerol phenylbutyrate) for the treatment of urea cycle disorders
+ AstraZeneca’s Ebymect (dapagliflozin/metformin) and Edistride (dapagliflozin) to control blood sugar in type II diabetics.
Five generic medicines have also been given positive CHMP opinions:
+ Accord Healthcare’s Aripiprazole for the treatment of schizophrenia and prevention/treatment of manic episodes of bipolar 1 disorder
+ Menarini’s Ciambra (pemetrexed)
+ Hospira’s Pemetrexed
+ Medac’s Pemetrexed for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer
+ Mylan’s Cinacalcet for the treatment of hyperparathyroidism and parathyroid carcinoma