US FDA approves Italfarmaco’s drug for Duchenne muscle-wasting disorder

By Thomson Reuters Mar 21, 2024 | 5:47 PM

(Reuters) -The U.S. FDA has approved privately held Italfarmaco Group’s drug to treat Duchenne muscular dystrophy (DMD), an inherited muscle-wasting disorder, the health regulator said on Thursday.

The oral drug, to be sold under the brand name Duvyzat, is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD, according to the FDA.

Duvyzat has been approved for patients six years of age and older.

DMD affects an estimated one-in-3,500 male births worldwide, and most patients lack the protein dystrophin which keeps muscles intact.

Duvyzat, chemically known as givinostat, helps regulate a group of enzymes responsible for causing muscle damage and deterioration in DMD patients.

(Reporting by Sruthi Narasimha Chari and Mariam Sunny in Bengaluru; Editing by Krishna Chandra Eluri)