BioCentury
ARTICLE | Clinical News

PRO045 regulatory update

February 4, 2013 8:00 AM UTC

Prosensa said it now has Orphan Drug designation for all 6 of its Duchenne muscular dystrophy (DMD) compounds. FDA and EMA granted Orphan Drug designation to PRO052 and PRO055, while FDA granted Orphan Drug designation to PRO045 and PRO053. The 4 antisense oligoribonucleotides are in preclinical testing. PRO045 and PRO053 already have Orphan Drug designation in the EU, while drisapersen ( PRO051/ GSK2402968) and PRO044 already have Orphan Drug designation in the U.S. and EU. ...