Drug was approved on an ‘accelerated’ schedule due to pressing medical need
By Physician’s Briefing Staff HealthDay Reporter
FRIDAY, March 15, 2024 (HealthDay News) — On Thursday, the U.S. Food and Drug Administration announced the approval of Rezdiffra (resmetirom) to treat noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate-to-advanced fibrosis.
“Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” Nikolay Nikolov, M.D., acting director of the Office of Immunology and Inflammation in the FDA Center for Drug Evaluation and Research, said in an agency news release. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”
The FDA said that the drug was approved under an “accelerated” pathway because it addressed “an unmet medical need.”
Rezdiffra was approved based on data collected after a year as part of an ongoing 54-month trial. Those data assessed improvement in levels of liver scarring compared to patients who were taking a placebo. Between 24 and 36 percent of NASH patients taking 100 mg of Rezdiffra saw their NASH resolve and experienced no worsening of liver scarring, compared to 9 to 13 percent of those who received placebo, the FDA said. A similar ratio saw their NASH continuing but experienced no worsening of liver scarring, the agency said.
Side effects of Rezdiffra include diarrhea and nausea, and its label includes warnings regarding a risk for drug-induced liver toxicity and gallbladder issues. Rezdiffra should not be taken by patients with decompensated cirrhosis, the FDA said, and the drug may interact with statins.
The approval of Rezdiffra was granted to Madrigal Pharmaceuticals.
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