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


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