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BioWorld - Thursday, April 30, 2026
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Home » US FDA clears Santhera’s improved steroid, Agamree, for DMD
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US FDA clears Santhera’s improved steroid, Agamree, for DMD

Oct. 27, 2023
By Jennifer Boggs and Karen Carey
Less than two weeks after getting a thumbs-up from the EMA’s Committee for Medicinal Products for Human Use, Santhera Pharmaceutical AG’s vamorolone secured U.S. FDA approval for use in patients, 2 and older, with Duchenne muscular dystrophy (DMD). A first-in-class drug, vamorolone, branded Agamree, is expected to offer a safer alternative to the steroid therapy, which the company has said will remain a foundational treatment of DMD, even with the introduction of gene therapies.
BioWorld Regulatory Musculoskeletal FDA

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