Amicus Therapeutics Provides Positive Global Regulatory Updates From EMA and FDA Meetings for Fabry Monotherapy
MAA Submission for Full Approval Planned in European Union -- Company to Accelerate Submission Timeline for MAA Filing to 2Q15
NDA Submission for Accelerated Approval (Subpart H) Planned in United States for 2H15
Conference Call and Webcast Today at 8:00 a.m. ET
CRANBURY, N.J., March 19, 2015 -- Amicus Therapeutics (FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced that it has met very recently with regulatory authorities in Europe and the U.S. to discuss the approval pathways for the oral small molecule pharmacological chaperone migalastat HCl ("migalastat") as a precision medicine monotherapy for Fabry patients who have amenable genetic mutations.
- Published: 19 March 2015
- Written by Editor