Amicus Therapeutics, a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted Accelerated Assessment to the oral small molecule pharmacological chaperone migalastat hydrochloride ("migalastat") monotherapy for Fabry patients who have amenable genetic mutations.

John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, "The designation of Accelerated Assessment in the European Union (EU) demonstrates that the EMA understands the current unmet medical need in Fabry disease as a major public health interest, and with this designation may accelerate the approval and our launch timelines to make migalastat available for patients very rapidly. This is excellent news for so many citizens in the EU and in other geographies around the world. As part of our global strategy, we also plan to submit our new drug application for U.S. approval in the second half of this year. We are committed to getting this personalized medicine approved as quickly as possible for Fabry patients with amenable genetic mutations around the world."

For more details, go to: http://files.shareholder.com/downloads/AMTX/228068399x0x831667/09da86ca-1def-43d5-9849-1096796f7545/FOLD_News_2015_5_26_General.pdf