ReveraGen BioPharma Receives FDA Fast Track Designation for Vamorolone for the Treatment of Duchenne Muscular Dystrophy
ROCKVILLE, Maryland, March 24, 2017
ReveraGen BioPharma Inc, a privately held corporation, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for vamorolone (VBP15) for the treatment of patients with Duchenne muscular dystrophy. This designation can speed the review of efficacy and safety data for vamorolone in boys with DMD, potentially leading to more rapid regulatory approval. Vamorolone is under parallel guidance from the FDA and the European Medicines Agency (EMA).