BioCentury
ARTICLE | Clinical News

Galafold migalastat regulatory update

April 11, 2016 7:00 AM UTC

EMA’s CHMP recommended approval of Galafold migalastat from Amicus as a long-term treatment for Fabry’s disease in patients ages >=16 who have an amenable mutation. The biotech said such mutations are found in 35-50% of Fabry’s patients. Amicus expects a decision from the European Commission this quarter. ...