Six months after buying CymaBay Therapeutics for $4.3 billion, Gilead has secured accelerated approval for seladelpar, the primary biliary cholangitis drug that was at the heart of the takeover.
The drug, which will be sold under the brand name Livdelzi, will cost $12,606 for a 30-day supply. It’s approved for patients who haven’t had good results on ursodeoxycholic acid, a naturally occurring bile acid that seeks to replace more toxic acids in the body. Ipsen says its Genfit-partnered Iqirvo has an $11,500 price tag for a one-month supply, while Intercept’s Ocaliva costs about $10,000, according to drugs.com, which tracks prices.
The approval is a critical, if expected, success as Gilead looks to bolster its portfolio of liver drugs. Primary biliary cholangitis, or PBC, is a rare autoimmune liver condition that injures the bile ducts and affects about 130,000 Americans, primarily women. The prevalence is higher in North America than in Europe or Asia, researchers have found.
Johanna MercierAs it prepares to compete against existing drugs, Gilead commercial chief Johanna Mercier emphasized seladelpar’s success at treating itching sensations in a Phase 3 study as validation for the higher price. But the company knows it’s up against more entrenched competitors, she said in an interview with Endpoints News.
“Because we are not first to market, we are also looking at the current marketplace,” Mercier said. “We’ll of course value that accordingly.”
Gilead plans to lean on the sales team’s relationships with physicians who are familiar with the company’s work treating hepatitis. Mercier, a longtime Bristol Myers Squibb executive who joined Gilead in 2019, said seladelpar fits “perfectly in our wheelhouse.” Peak sales estimates for the drug range from $500 million to $1.5 billion, according to analysts.
“We believe we can make a real difference here and potentially be north of that estimate,” she said.
The approval was based primarily on Phase 3 results from almost a year ago showing that the drug reduced biomarkers associated with PBC by 61.7%, compared with a 20% reduction for patients given placebo. CymaBay also reported then that treated patients had a statistically significant improvement in itch symptoms compared to placebo.
Next month, experts on an FDA advisory committee will consider whether to support full approval for Ocaliva, the drug from Intercept (the company is now owned by Italian specialty drug company Alfasigma).
Mercier wouldn’t put a deadline on when Gilead expects to get its own review for a full approval, noting that an ongoing Phase 3 trial testing seladelpar in patients with PBC and compensated cirrhosis is enrolling. She said it “might take a little bit of time” before a full dataset is in hand; the clinical trial record of the study says the primary completion date is July 2029.
And Gilead has no immediate plans to tack on primary sclerosing cholangitis as an indication to seladelpar, according to Mercier, who says the company’s full attention is on executing the PBC rollout. The condition is very similar to PBC and differs in the bile ducts that are impacted by the body’s harmful autoimmune response.