Proactive Investors - Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) shares soared after the biopharmaceutical firm revealed its live disease drug Rezdiffra has won US Food and Drug Administration (FDA) approval.
Shares of the company gained 18.9% at about $290 in early trade on Friday.
Madrigal’s Rezdiffra in conjunction with diet and exercise was approved by the FDA to treat adults with noncirrhotic non-alcoholic steatohepatitis (NASH), also known as MASH, with moderate to advanced liver fibrosis.
It marks the first FDA-approved therapy for NASH, a serious and progressive liver disease.
The company expects the once-daily, oral drug will be available to patients in the US starting in April, distributed through a specialty pharmacy network.
The prescribing information does not include a liver biopsy requirement for diagnosis, it added.
The accelerated FDA approval was based on Phase 3 clinical trial data demonstrating that Rezdiffra improved liver fibrosis and resolved NASH in patients with noncirrhotic NASH with moderate to advanced liver fibrosis, Madrigal said.
“We believe Rezdiffra will change the treatment paradigm for NASH with moderate to advanced liver fibrosis, giving physicians a liver-directed therapy to help improve fibrosis and resolve NASH before their patients progress to cirrhosis,” Madrigal chief medical officer Dr. Becky Taub said in a statement.
Fatty Liver Foundation CEO Wayne Eskridge added: “This is a day of celebration for patients with NASH who have been waiting many years for the first approved therapy.”