Catalyst Pharmaceuticals to Commercialize Duchenne Treatment in 1Q24 After FDA Approval
By Ben Glickman
Catalyst Pharmaceuticals said that it would commercially launch Agamree, a treatment for Duchenne Muscular Dystrophy, after the treatment was approved by the U.S. Food and Drug Administration.
Catalyst holds the exclusive North American license to commercialize Agamree, which was developed by Santhera Pharmaceuticals. Catalyst secured the rights in July.
The Coral Gables, Fla.-based pharmaceutical company said Thursday that Agamree oral suspension of 40 mg/ml had been approved by the FDA to treat Duchenne in patients two years and older. Catalyst plans to launch commercially in the first quarter of 2024.
The treatment was Orphan Drug and Rare Pediatric Disease status for Duchenne in the U.S., meaning Catalyst will have exclusivity for seven years.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
October 26, 2023 15:49 ET (19:49 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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