Post by guruzim on Jun 8, 2015 6:04:12 GMT
Amicus Therapeutics Submits Marketing Authorization Application (MAA) for Full Approval of Fabry Monotherapy Galafold(TM) (Migalastat) in European Union
MAA Submission Under "Accelerated Assessment"
Brand Name Galafold(TM) Approved by Regulatory Authorities in EU and U.S.
CRANBURY, N.J., June 3, 2015 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, has submitted a marketing authorization application (MAA) to request full approval of the oral small molecule pharmacological chaperone Galafold (migalastat HCl) for Fabry patients who have amenable genetic mutations. The brand name Galafold has been approved by both the European Medicines Agency (EMA) as well as the U.S. Food and Drug Administration (FDA).
"This filing represents the single greatest milestone in the history of Amicus," stated John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics. "The MAA submission for Galafold is the first marketing application for Amicus. This comprehensive regulatory submission is the result of the tireless efforts of so many Amicus employees, investigators, consultants and, most importantly, the Fabry patients who have volunteered to participate in our clinical trials over the years. Our goal now is crystal clear: to bring this novel small molecule, orally bioavailable personalized medicine to as many people living with this devastating genetic disease as quickly as possible. We could not be more proud of our team and thankful to the entire Fabry community as we are today."
MAA Submission Under "Accelerated Assessment"
Brand Name Galafold(TM) Approved by Regulatory Authorities in EU and U.S.
CRANBURY, N.J., June 3, 2015 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, has submitted a marketing authorization application (MAA) to request full approval of the oral small molecule pharmacological chaperone Galafold (migalastat HCl) for Fabry patients who have amenable genetic mutations. The brand name Galafold has been approved by both the European Medicines Agency (EMA) as well as the U.S. Food and Drug Administration (FDA).
"This filing represents the single greatest milestone in the history of Amicus," stated John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics. "The MAA submission for Galafold is the first marketing application for Amicus. This comprehensive regulatory submission is the result of the tireless efforts of so many Amicus employees, investigators, consultants and, most importantly, the Fabry patients who have volunteered to participate in our clinical trials over the years. Our goal now is crystal clear: to bring this novel small molecule, orally bioavailable personalized medicine to as many people living with this devastating genetic disease as quickly as possible. We could not be more proud of our team and thankful to the entire Fabry community as we are today."
