Key takeaways:
- Hepcludex injection was approved for chronic hepatitis D without cirrhosis or with compensated cirrhosis.
- It is the first FDA-approved treatment for the disease.
Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA approved Hepcludex injection for the treatment of chronic hepatitis D infection in adults without cirrhosis or with compensated cirrhosis, according to a press release.
The FDA approved Hepcludex injection for the treatment of chronic hepatitis D.
Hepcludex (bulevirtide-gmod, Gilead Sciences) is the first FDA-approved treatment for the condition.
“Today’s approval fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA-approved therapies available,” Wendy Carter, DO, acting director of the Office of Infectious Diseases at FDA’s Center for Drug Evaluation and Research, said in the release. “For individuals living with this chronic viral infection, this new treatment option offers hope in managing a disease that can rapidly progress to serious liver complications.”
The approval was based on data from the phase 3 MYR301 trial, which tested once-daily Hepcludex 8.5 mg. At 48 weeks, 48% of patients given Hepcludex met the primary efficacy endpoint of combined response vs. 2% of those who underwent a 48-week treatment delay.
The drug comes with possible side effects including anaphylaxis, injection site reactions, headaches, abdominal pain, fatigue and itching. There is a boxed warning that discontinuing the drug can severely, acutely exacerbate HDV and hepatitis B virus infection.
The FDA previously granted Hepcludex breakthrough therapy designation and orphan drug designation.
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