Amicus Therapeutics Plans To Submit MAA To EMA In Mid-2015 - Quick Facts

(RTTNews) - Amicus Therapeutics (FOLD) announced it has conducted a successful pre-submission meeting with the European Medicines Agency, or EMA, to discuss the registration of migalastat HCl monotherapy for the treatment of Fabry disease.

Migalastat is an oral small molecule pharmacological chaperone in development for Fabry patients with amenable mutations. Amicus has begun preparing a marketing authorization application that it plans to submit to the EMA in the middle of 2015 under the Centralized Procedure.

John Crowley, CEO of Amicus Therapeutics, said: "We also look forward to meeting with the FDA in the first quarter of 2015 to discuss the U.S. regulatory path."