(Bloomberg) -- Gilead Sciences Inc. won approval from US regulators for Livdelzi, a liver disease drug the company acquired with its $4.3 billion purchase of CymaBay Therapeutics earlier this year.
Livdelzi, a once-daily pill, will cost $12,606 for a 30-day supply, a Gilead spokesperson said. The company anticipates that most insurers will cover the drug.
The drug treats a rare disease that damages the liver’s bile ducts, which can cause liver failure. About 130,000 people in the US, mostly women, suffer from the disease, according to Gilead. Other treatments can offer relief but don’t work for all patients.
Gilead has long focused on liver disease drugs, helping to develop treatments for the viral liver infection hepatitis C. Livdelzi treats primary biliary cholangitis, or PBC. Gilead’s liver drug salespeople already have relationships with about 80% of US doctors who might treat patients with PBC, according to the company.
The company’s shares rose less than 1% at the market close on Wednesday in New York. The stock has declined 8.5% this year.
The Food and Drug Administration greenlit Livdelzi using the accelerated approval pathway, which allows drugmakers to market treatments based on early data so patients with limited options don’t have to wait on lengthy clinical trials. A phase 3 study showed that the drug improved biological markers of the disease and relieved itching, a common side effect. A clinical trial is ongoing to see if the drug delays severe liver damage or death.
Gilead says timing of the study results will be contingent on how fast it enrolls patients. Johanna Mercier, Gilead’s chief commercial officer, declined to say what the company would do if the trial fails.
(Adds shares. In an earlier version, company corrected timing of study results.)
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