US FDA approves Santhera's drug for rare muscular dystrophy (updated)

Santhera Pharmaceuticals Holding AG

26/10/2023 20:37

(Recasts paragraph 1, adds details on the approval, launch of
the drug from paragraph 2 onward)
       Oct 26 (Reuters) - Catalyst Pharmaceuticals  CPRX.O 
said on Thursday that U.S. health regulators have approved its
partner Santhera Pharmaceuticals'  SANN.S  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)
 ((Leroy.Dsouza@thomsonreuters.com ; https://twitter.com/LeroyLeo7;))