Madrigal Reveals Accelerated FDA Approval Of Rezdiffra (resmetirom) For Treatment Of Patients With Noncirrhotic NASH With Moderate To Advanced Liver Fibrosis
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Madrigal Pharmaceuticals has received accelerated FDA approval for Rezdiffra (resmetirom) for treating noncirrhotic NASH with moderate to advanced liver fibrosis. The approval is conditional on further verification from ongoing trials. Rezdiffra, which does not require a liver biopsy for diagnosis, has dosages based on body weight and will be available in the U.S. in April through a specialty pharmacy network.
March 14, 2024 | 8:22 pm
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Madrigal Pharmaceuticals receives accelerated FDA approval for Rezdiffra, a treatment for noncirrhotic NASH with moderate to advanced liver fibrosis.
The accelerated FDA approval of Rezdiffra is a significant milestone for Madrigal Pharmaceuticals, likely leading to increased investor confidence and potential revenue growth. The absence of a liver biopsy requirement could make Rezdiffra a preferred treatment option, further boosting its market potential. However, the conditional nature of the approval, pending further trial results, introduces some uncertainty.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100