Shire Submits European Marketing Authorization Application (MAA) for velaglucerase alfa for the Treatment of Type 1 Gaucher Disease
Tue, 11/24/2009 - 3:36am
Shire plc has submitted a MAA to the European Medicines Agency for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. This is the third marketing application for velaglucerase alfa that has been submitted, with previous submissions in the United States and Canada. Based on a global supply shortage of the currently approved and marketed treatment for patients with Gaucher disease, and positive results from all three velaglucerase alfa Phase III trials, CHMP has accepted the company's request for an accelerated assessment of the velaglucerase alfa MAA. The MAA review is expected to begin in the December cycle. Under accelerated assessment, the review timeline of the MAA is shortened from 210 days to 150 days.