Italfarmaco Group Completes FDA Submission of New Drug Application for Givinostat in Duchenne Muscular Dystrophy and Receives Priority Review
Italfarmaco Group said Thursday that submission based on completed Phase 3 program in 179 boys has demonstrated significant slowing of disease progression with a good safety and tolerability profile. The company said that the PDUFA goal date set for December 21, 2023.