FDA approves Duvyzat for Duchenne muscular dystrophy

Yesterday, the US Food and Drug Administration (FDA) approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular dystrophy (DMD) in patients six years of age and older, from privately-held Italian pharma company Italfarmaco.

Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle.

“The FDA’s approval of Duvyzat for DMD, based on our robust and successful clinical development program, reflects Italfarmaco’s commitment to providing a safe and proven-effective therapy that can have a meaningful impact for people living with DMD,” said Dr Paolo Bettica, chief medical officer of Italfarmaco. “We are grateful for the support of those living with DMD and their dedicated caregivers, which played a central role in helping us reach this landmark FDA approval. Our focus now is to make Duvyzat available as a treatment for DMD management in the U.S. as quickly as possible,” he added.