EMA Highlights: Green light for new medicines

by Gary Finnegan: The European Medicines Agency’s key committee approved a total of 19 new medicines at its meeting in late September – the highest number of products to get the green light this year. This brings the total number of approvals by the Committee for Medicinal Products for Human Use (CHMP) to 74.

The Committee recommended granting a marketing authorisation, under accelerated assessment, for Praxbind (idarucizumab) as a specific antidote to the anticoagulant medicine Pradaxa (dabigatran etexilate), when rapid reversal of its effect is required.

In addition, the following received positive recommendations:

• Entresto (sacubitril/valsartan) was recommended for the treatment of symptomatic chronic heart failure with reduced ejection fraction – a condition where the heart muscle does not contract effectively and less oxygen-rich blood is pumped out to the body.
• Kyprolis (carfilzomib) to treat patients with multiple myeloma whose disease has relapsed after receiving at least one prior course of therapy. Kyprolis is for use in combination with the medicines lenalidomide and dexamethasone. Kyprolis has an orphan designation and was reviewed under accelerated assessment.
• Blincyto (blinatumomab) for the treatment of Philadelphia chromosome-negative acute lymphoblastic leukaemia. .
• Cotellic (cobimetinib) for the treatment of metastatic melanoma.
• Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) for the treatment of Human Immunodeficiency Virus (HIV) infection.
• Nucala (mepolizumab) for the treatment of asthma
• Orkambi (lumacaftor ivacaftor) for the treatment of cystic fibrosis..
• Numient (levodopa/carbidopa) for the treatment of Parkinson’s disease.
• Ionsys (fentanyl) for the treatment of post-operative pain,
• Elocta (efmoroctocog alfa) for the treatment of haemophilia A.
• Ravicti (glycerol phenylbutyrate) for the treatment of urea cycle disorders.
• Ebymect (dapagliflozin/metformin) and Edistride (dapagliflozin) for the treatment of type 2 diabetes mellitus.

Five generic medicines received positive opinions from the CHMP:

• Aripiprazole Accord (aripiprazole) for the treatment of schizophrenia and the prevention and treatment of manic episodes of bipolar 1 disorder.
• Ciambra (pemetrexed), Pemetrexed Hospira (pemetrexed) and Pemetrexed Medac (pemetrexed) all to be used for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer.
• Cinacalcet Mylan (cinacalcet) for the treatment of hyperparathyroidism and parathyroid carcinoma.

The Committee recommended extensions of indication for Eylea, Gilenya, Kalydeco, Opdivo, Rebetol and Vidaza.