Catalyst launches AGAMREE (vamorolone) in US for Duchenne Muscular Dystrophy

CATALYST PHARMACEUTICALS, INC.

AGAMREE (vamorolone) oral suspension 40 mg/mL now commercially available by prescription for DMD patients aged 2+.
FDA approved Oct 26, 2023; launch follows approval with nationwide specialty pharmacy network.
Pivotal Phase 2b VISION-DMD study showed comparable efficacy with reduced bone health and growth side effects vs. standard corticosteroids.
Catalyst Pathways patient support program provides one-on-one education and financial assistance for eligible patients.
DMD affects ~11,000–13,000 US patients; ~70% currently on corticosteroid therapy.

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