FDA approves Madrigal Pharmaceuticals’ Rezdiffra

The FDA granted approval to Madrigal Pharmaceuticals’ Rezdiffra, a thyroid hormone receptor-beta agonist, in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis, or NASH, with moderate to advanced liver fibrosis consistent with stages F2 to F3 fibrosis. “This indication is approved under accelerated approval based on improvement of NASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials,” the FDA label stated.