Italfarmaco’s Duvyzat backed by MHRA

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorization for Duvyzat (givinostat) to treat Duchenne muscular dystrophy (DMD).

The new conditional marketing authorization was granted to privately-held Italian drugmaker Italfarmaco.

“This approval is based on our robust, clinically meaningful, successful development program in one of the largest DMD trials to-date,” said Dr Paolo Bettica, chief medical officer at Italfarmaco Group. “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 MHRA approval. Our focus now is to make Duvyzat available as a treatment for DMD management in the UK as quickly as possible,” he added.