Amicus' Galafold wins accelerated approval from FDA

FDA granted accelerated approval to Galafold migalastat from Amicus Therapeutics Inc. (NASDAQ:FOLD) to treat Fabry disease in adults who have amenable mutations. Amicus said the U.S. approval is the first for a new Fabry disease therapy in more than 15 years.

Amicus plans to launch Galafold immediately in the U.S., and intends to reveal its U.S. price during an Aug. 13 conference call. The small molecule stabilizer of α galactosidase A is also approved in the EU, Japan and five other countries...