Key Takeaways:
The U.S. Food and Drug Administration granted accelerated approval to Gilead Sciences Inc.’s (GILD) Hepcludex, making it the first and only approved treatment in the United States for the rare and severe chronic hepatitis delta virus (HDV) infection.
"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, acting director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research, said in a statement.
The approval of the 8.5 mg daily injection targets an estimated 40,000 to 80,000 people in the U.S. living with HDV, the most severe form of viral hepatitis. The decision was based on the Phase 3 MYR301 study, where patients at week 48 showed a statistically significant improvement in combined virologic and biochemical responses versus a control group.
Chronic HDV, which only affects people already infected with hepatitis B, leads to rapid disease progression and can have mortality rates as high as 50% within five years in patients with cirrhosis. Hepcludex works by blocking the entry of the virus into liver cells.
The FDA's accelerated approval is contingent upon verification of clinical benefit in a confirmatory trial, which Gilead has already initiated. The new approval provides a significant, unopposed market opportunity for Gilead in a disease area with high unmet need.
This article is for informational purposes only and does not constitute investment advice.
