Gilead Sciences Receives Accelerated Approval from FDA

By Connor Hart

Gilead Sciences received accelerated approval from the Food and Drug Administration for Livdelzi, its drug that treats primary biliary cholangitis, a chronic autoimmune disease that causes inflammation and scarring of the liver's bile ducts.

The Foster City, Calif., biopharmaceutical company on Wednesday said the accelerated approval was based primarily on data from a Phase 3 study, in which 62% of participants taking Livdelzi achieved the primary endpoint of composite biochemical response after a year, versus 20% of participants taking placebo.

Treatment with Livdelzi led to normalization of alkaline phosphatase values, a predictor of risk for liver transplant and death, in 25% of trial participants after a year, whereas no change was seen in trial participants receiving placebo.

The FDA approved Livdelzi under accelerated approval to reduce alkaline phosphatase values. Improvement in survival or prevention of liver decompensation events haven't been demonstrated, and continued approval of Livdelzi may require additional trials.

Primary biliary cholangitis is rare, affecting about 130,000 Americans, most of which are women, and can cause liver damage and possible liver failure if untreated. The disease currently has no cure.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

August 14, 2024 14:36 ET (18:36 GMT)

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