Madrigal says it's 'well on the way' to potential NASH launch ahead of FDA decision: #JPM24
11 Jan 2024
Accelerated ApprovalDrug Approval
SAN FRANCISCO — Madrigal Pharmaceuticals will be “ready to go” if the FDA grants its nonalcoholic steatohepatitis hopeful an accelerated approval in March, the company’s new CEO Bill Sibold said Wednesday.
Resmetirom would be the first approved treatment in an area that’s seen failure after failure, including Intercept’s closely watched FXR agonistFXR agonist obeticholic acid, which was rejected for a second time in June following safety concerns. Madrigal completed its submission shortly after Intercept’s CRL, though its candidate relies on a different mechanism of action known as thyroid hormone beta-receptor agonism.
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Source: EndPoints
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