Health Canada speeds up its review of givinostat for Duchenne

Health Canada speeds up its review of givinostat for Duchenne

Health Canada has accepted and granted priority review to Italfarmaco’s application seeking the approval of oral givinostat, sold in the U.S. under the brand name Duvyzat, to treat Duchenne muscular dystrophy (DMD). The priority review status is reserved for therapies that could significantly improve the benefit-risk profile over current treatments. This designation shortens the evaluation to a 180-day target, meaning a regulatory decision could…