Nineteen new therapies – including an antidote to the bloodthinner Pradaxa, a treatment for the rare blood cancer multiple myeloma, and a new drug for Parkinson’s disease – have taken a giant leap closer to being granted entry to the European market.
In its busiest meeting of the year so far, 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; and
- AstraZeneca’s Ebymect (dapagliflozin/metformin) and Edistride (dapagliflozin) to control blood sugar in type II diabetics.
Five generic medicines also picked up 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 and Medac’s Pemetrexed for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer; and Mylan’s Cinacalcet for the treatment of hyperparathyroidism and parathyroid carcinoma.
