FDA Approves Novel Corticosteroid Treatment Option for DMD Patients

The FDA on Thursday approved Santhera Pharmaceuticals’ novel corticosteroid vamorolone, now to carry the brand name Agamree, for the treatment of Duchenne muscular dystrophy.

The announcement was made by Florida-based Catalyst Pharmaceuticals, which in June 2023 paid $90 million upfront and promised up to $141 million more in milestones to exclusively commercialize the drug in North America. As part of the deal, Santhera will now transfer the approved New Drug Application for Agamree to Catalyst, which expects to launch the product in the first quarter of 2024.