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Italfarmaco S.p.A.’s Duvyzat Approved by FDA

Orally administered treatment for Duchenne muscular dystrophy approved in patients 6 years and older.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has approved Italfarmaco S.p.A.’s Duvyzat (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD), a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from early childhood.   “The FDA’s approval of Duvyzat for DMD, based on our robust and successful clinical development program, reflects Italfarmaco’s commitment to providing a saf...

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