(Reuters) -Catalyst Pharmaceuticals said on Thursday that U.S. health regulators have approved its partner Santhera Pharmaceuticals’ drug to treat Duchenne muscular dystrophy (DMD), a rare muscle-wasting disorder, in patients two years of age and older.
Swiss firm Santhera had licensed the rights for the manufacturing and supply of the drug in North America to Catalyst.
The U.S. Food and Drug Administration’s approval for the drug, branded as Agamree, comes just months after the approval of Sarepta Therapeutics’ Elevidys, the first gene therapy for DMD.
Catalyst Pharmaceuticals said it expect to launch Agamree in the first quarter of 2024.
The companies did not immediately respond to Reuters requests for comment on the drug’s pricing.
DMD is a muscle-wasting disorder that is estimated to affect one in 3,500 male births worldwide, according to the National Organization for Rare Disorders, and patients rarely survive beyond their thirties.
(Reporting by Leroy Leo and Khushi Mandowara in Bengaluru; Editing by Maju Samuel and Shailesh Kuber)
