By SPC Staff
The FDA approved givinostat (Duvyzat, Italfarmaco S.p.A.) oral medication for Duchenne muscular dystrophy (DMD) in patients aged 6 years of age and older.
Givinostat is the first nonsteroidal drug to treat patients with all genetic variants of the disease, the agency noted. The drug is a histone deacetylase inhibitor that reduces inflammation and loss of muscle.
The approval was based on data from a randomized, double-blind, placebo-controlled, phase 3 study