Alfasigma wins FDA approval for liver disease itch treatment

Rare Daily Staff

The U.S. Food and Drug Administration has approved Alfasigma’s linerixibat to treat severe itching in adults with primary biliary cholangitis, marking the first therapy specifically developed for this condition, the company said Thursday.

Italy-based Alfasigma announced the decision a week after signing a licensing agreement with GSK that gives it worldwide exclusive rights to develop, manufacture, and commercialize the drug.

Primary biliary cholangitis, or PBC, is a rare, chronic liver disease in which the body’s immune system slowly destroys bile ducts in the liver. This damage causes bile to build up, leading to inflammation, scarring, and, over time, liver failure. One of the most burdensome symptoms is cholestatic pruritus, a persistent and sometimes severe itching that can significantly disrupt sleep and quality of life.

Linerixibat is designed to target that symptom directly. The oral therapy works by inhibiting bile acid reabsorption in the intestine, reducing the buildup of substances believed to trigger itching. Its approval in the United States is based on data from the phase 3 GLISTEN trial, which showed meaningful reductions in itch severity compared with placebo.

Francesco Balestrieri, CEO of Alfasigma, called the approval “an important milestone” for patients, noting that the company plans to leverage its experience in liver disease to lead global commercialization efforts.

Linerixibat is now approved in the United States, while regulatory reviews are ongoing in the United Kingdom, European Union, China, and Canada.