In December of 2020, when Gilead acquired MYR of Germany and its hepatitis D virus drug—which was already authorized for use in Europe—the California company said it would “accelerate” the global launch of the treatment.
Nearly two years later, Gilead has yet to gain sanction for the drug, called bulevirtide, in the U.S., and it’s not happening any time soon as the FDA has given it a thumbs down.
In its complete response letter, the regulator cited manufacturing and delivery concerns with the drug. The company revealed the rejection on Thursday afternoon as it presented its third quarter earnings.
“We will take the time to fully digest the CRL but note that no new safety or clinical trials were requested by the FDA,” Gilead’s chief medical officer Merdad Parsey, M.D., Ph.D., said in during a conference call. “We plan to resubmit as quickly as possible and we’ll work with the agency on the path forward.”
It is the second manufacturing-related CRL in eight months for Gilead, which also got an FDA rejection notice for HIV prospect lenacapavir in March. The FDA has recently accepted a refiling for the long-acting HIV candidate after Gilead changed the product’s vial to fix a compatability problem. That drug was sanctioned in Europe and the U.K. last month.
As for bulevirtide, the entry inhibitor was the key piece in Gilead’s purchase of MYR for 1.15 billion euros. It received orphan drug status in the U.S. in 2015 and was launched in Europe under the brand name Hepcludex in September of 2020.
In June, Gilead released results of a trial that showed it provided significant viral declines after 48 weeks of treatment. The condition is referred to as a satellite virus because it only infects those with hepatitis B.
Hepatitis D infects roughly 5% of those with Hepatitis B, or roughly 12 million worldwide and is often fatal. Hepcludex is the first treatment available for the virus, which is transmitted through broken skin via sexual contact or contact with tainted syringes.