FDA Approves First Drug to Treat Liver Scarring in Fatty Liver Disease

• FDA approves Rezdiffra as first treatment for liver scarring due to fatty liver disease

• Rezdiffra showed ability to resolve NASH and reduce liver scarring in 1-year trial

• Common side effects include diarrhea and nausea; has warnings on liver toxicity and gallbladder issues

• Approved under accelerated pathway based on surrogate endpoint; further trial ongoing

• Breakthrough Therapy, Fast Track and Priority Review designations granted