EMA Highlights: Green light for new medicines

by Gary Finnegan: Six new medicines, two of which had been fast-tracked, were given positive reviews from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This clears the way for the final approval by the European Commission.

The CHMP recommended granting a marketing authorisation, under accelerated assessment, for Empliciti (elotuzumab) for the treatment of multiple myeloma. Empliciti is to be used in combination with lenalidomide and dexamethasone for the treatment of patients who have received at least one prior therapy. Empliciti has an orphan designation.

Coagadex (factor X), for the treatment of factor X deficiency, a rare inherited bleeding disorder. Coagadex has an orphan designation and was reviewed under accelerated assessment.

Uptravi (selexipag) was recommended by the Committee for the treatment of pulmonary arterial hypertension. Uptravi has an orphan designation.

Three generic medicines received a positive opinion from the Committee:

• Amlodipine-Valsartan Mylan(amlodipine/valsartan) for the treatment of essential hypertension,
• Rasagiline Mylan(rasagiline) for the treatment of idiopathic Parkinson’s disease
• Zonisamide Mylan(zonisamide) for the treatment of partial seizures, with or without secondary generalisation.