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# GSK NDA Accepted for Hepatitis B Drug
- URL: https://www.fdaweb.com/gsk-nda-accepted-for-hepatitis-b-drug/
- Published: 2026-04-29T12:00:00.000Z
- Updated: 2026-09-14T13:38:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161065

FDA has accepted for priority review a GSK NDA for its investigational hepatitis B treatment bepirovirsen. The agency set a user fee review action target date of 10/26.

The investigational antisense oligonucleotide is being developed for adults with chronic hepatitis B, a viral infection that affects more than 250 million people globally and about 1.7 million in the U.S. The disease is a leading cause of liver cancer and is responsible for roughly 1.1 million deaths each year worldwide, according to the company.

GSK says the application is supported by data from the late-stage B-Well 1 and B-Well 2 trials, which demonstrated statistically significant and clinically meaningful functional cure rates when bepirovirsen was added to standard therapy compared with standard treatment alone. Functional cure — defined as sustained absence of hepatitis B virus DNA and surface antigen in the blood after stopping therapy — remains rare with current treatments, typically occurring in about 1% of patients, it adds.

Bepirovirsen works by targeting and degrading viral genetic material, suppressing production of hepatitis B surface antigen and potentially enabling the immune system to regain control of the infection, according to the company. The drug is being licensed from Ionis Pharmaceuticals.