CHMP News – September 2015
19 new medicines receive positive opinions from the Committee
At its busiest meeting of 2015 so far, the Committee for Medicinal Products for Human Use (CHMP) recommended 19 new medicines for marketing authorisation.
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. Praxbind is to be used when a patient taking Pradaxa needs to undergo an emergency surgery or when life-threatening or uncontrolled bleeding occurs. For more information on Praxbind, please see the press release on the EMA webpages or here.
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. For more information on Entresto, please see the press release on the EMA webpages or here.
The Committee recommended granting a marketing authorisation for 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. For more information on Kyprolis, please see the press release on the EMA webpages or here.
The CHMP recommended granting a conditional marketing authorisation for Blincyto (blinatumomab) for the treatment of Philadelphia chromosome-negative acute lymphoblastic leukaemia. Conditional marketing authorisations are one of the mechanisms put in place by the EMA to facilitate market access for medicines that fulfill unmet medical needs. Blincyto has an orphan designation.
Cotellic (cobimetinib) was recommended by the Committee for the treatment of metastatic melanoma.
Genvoya (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide) received a positive opinion from the Committee for the treatment of Human Immunodeficiency Virus (HIV) infection.
The CHMP recommended Nucala (mepolizumab) for the treatment of asthma and Orkambi (lumacaftor / ivacaftor) for the treatment of cystic fibrosis. Orkambi has an orphan designation.
Numient (levodopa / carbidopa) received a positive opinion from the Committee for the treatment of Parkinson’s disease.
The Committee also granted positive opinions for Ionsys (fentanyl) for the treatment of post-operative pain, as well as Elocta (efmoroctocog alfa) for the treatment of haemophilia A. Elocta has an orphan designation.
Ravicti (glycerol phenylbutyrate), which also has an orphan designation, received a positive opinion from the Committee for the treatment of urea cycle disorders.
Ebymect (dapagliflozin / metformin) and Edistride (dapagliflozin) received positive opinions 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, and Cinacalcet Mylan (cinacalcet) for the treatment of hyperparathyroidism and parathyroid carcinoma.
Six recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Eylea, Gilenya, Kalydeco, Opdivo, Rebetol and Vidaza.
More on the CHMP September 2015 meeting is accessible on the EMA webpages or here.