FDA sets spring decision date for Madrigal’s NASH treatment, days after company announced new CEO
Madrigal Pharmaceuticals announced Wednesday that the FDA has set a March deadline for its decision on Madrigal’s treatment for a liver disease called nonalcoholic steatohepatitis, or NASH. If approved, resmetirom would become the first commercially available treatment specifically for NASH.
The FDA’s deadline is March 14, and the regulator does not plan to hold an advisory committee meeting, according to Madrigal’s release. The company is seeking accelerated approval of resmetirom based on one-year results from a Phase III study that suggested more patients who received the treatment saw NASH resolution and improved liver scarring compared to those who got placebo.
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