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U.S. FDA gives early approval to Sarepta’s DMD therapy

FILE PHOTO: The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland November 4, 2009. REUTERS/Jason Reed/File Photo

(This December 12 story corrects to remove reference to gene therapy in headline and first paragraph)

(Reuters) – The U.S. Food and Drug Administration on Thursday granted an early approval to Sarepta Therapeutics Inc’s therapy for Duchenne muscular dystrophy (DMD).

DMD is a rare, genetic disorder that hampers muscle movement mainly in men, affecting one in every 3,500 to 5,000 males.

It can cause life-threatening damage to the heart, and over time, death, often at a young age.

Reporting by Dania Nadeem in Bengaluru; Editing by Sriraj Kalluvila

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