Gilead gets US FDA approval for inflammatory liver disease drug

By Puyaan Singh and Leroy Leo

(Reuters) -The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences' liver disease treatment, Livdelzi, which it gained through a $4.3 billion buyout of CymaBay Therapeutics earlier this year.

The disease, primary biliary cholangitis (PBC), causes inflammation of the small bile ducts in the liver and can eventually destroy them. It mainly affects women aged 35 to 60.

The American Liver Foundation estimates that about 65 out of every 100,000 women in the U.S. have PBC.

Livdelzi's list price is $12,606 per 30 days of therapy. Rival drug, Iqirvo, from Ipsen costs $11,500 per month.

BMO Capital Markets analyst Evan Seigerman sees $847 million in annual peak sales for Livdelzi, accelerating growth for Gilead's liver drug portfolio, which posted a 17% increase in second-quarter revenue.

Gilead expects the drug to have modest sales in the first couple of quarters, before sales become "much more meaningful in 2025 and beyond", Chief Commercial Officer Johanna Mercier told Reuters.

Mercier said the drug was a "great strategic fit", given the company's experience with liver disease treatments.

The FDA's accelerated approval for Livdelzi is based on a 193-patient study, in which 62% of the participants who received a combination of the drug and ursodeoxycholic acid (UDCA) showed an improvement in biochemical response after one year.

About 40% of PBC patients do not respond to the generic drug UDCA as their first line of treatment, according to a study last year.

Gilead's once-daily pill also showed a statistically significant reduction in itching — a symptom that more than half of the PBC patients experience.

Treatment with Ipsen's Iqirvo has also not shown statistically significant reduction in itching, whereas Intercept Pharmaceuticals' Ocaliva can worsen itching.

The FDA's accelerated nod to Livdelzi can be converted to a standard approval if it shows improvement in survival or preventing liver function deterioration in a confirmatory study.

(Reporting by Puyaan Singh, Christy Santhosh and Leroy Leo in Bengaluru; Editing by Devika Syamnath and Shilpi Majumdar)