05:36 PM EDT, 03/14/2024 (MT Newswires) -- Madrigal Pharmaceuticals ( MDGL ) received the US Food and Drug Administration's accelerated approval of Rezdiffra for treating adults with noncirrhotic nonalcoholic steatohepatitis and moderate to advanced liver fibrosis, the company said Thursday.
Rezdiffra, which is a once-daily oral therapy, was approved in combination with diet and exercise, the company said. The approval was based on results from the ongoing phase 3 trial, involving 1,759 patients with biopsy-confirmed NASH.
Rezdiffra is expected to be available to US patients in April, through a limited specialty pharmacy network.
Madrigal shares were up 23% in after-hours activity.
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