The Food and Drug Administration on Wednesday approved a new treatment for primary biliary cholangitis, an autoimmune liver disease mainly affecting women that causes decreased liver function, debilitating itching, and fatigue.
The drug, called Livdelzi, will be sold by Gilead Sciences, following the $4.3 billion acquisition of CymaBay Therapeutics, its developer, earlier this year.
Regulators cleared Livdelzi for patients with primary biliary cholangitis, or PBC, that doesn’t respond adequately to initial treatment with a commonly used medicine. Gilead estimates there are approximately 130,000 people in the U.S. who are impacted by PBC, of which about 30,000 to 40,000 don’t respond to first-line therapy.
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