EU's CHMP recommends approval of Cerdelga for Gaucher Disease-Genzyme
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Cerdelga (eliglustat) capsules, from Genzyme, an oral treatment for certain adults living with Gaucher Disease type 1. The CHMP opinion was based on data from the Cerdelga clinical development program, which is the largest ever conducted in Gaucher disease, with approximately 400 patients treated in 29 countries. Genzyme has been researching an oral therapy for Gaucher disease for fifteen years. The most common adverse reactions (greater than or equal to 10%) are fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain. Cerdelga was approved by the U.S. Food and Drug Administration in August, and is under review by other regulatory authorities around the world.
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