Marathon's cheap, old steroid breezes through the FDA for Duchenne MD, and gets priced at $89K
For a simple systemic steroid that is cheap and easily available outside the US, deflazacort has received unusually careful support from the FDA, breezing through a regulatory process that has bedeviled several developers trying to address the root cause of the disease.
Deflazacort won a priority review from the agency as a new therapy for Duchenne muscular dystrophy — cutting four months off the regulatory process — along with an orphan drug designation and rare pediatric disease status. And today, the FDA handed Marathon Pharmaceuticals a green light to start marketing the drug to all boys 5 and older whose lives are being slowly destroyed by the disease.
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