GSK press release
28 April 2026 – GSK plc today announced that the US Food and Drug Administration (FDA) has accepted for priority review a New Drug Application (NDA) for bepirovirsen, an investigational antisense oligonucleotide (ASO), for the treatment of adults with chronic hepatitis B (CHB).
Bepirovirsen has also received Breakthrough Therapy Designation (BTD), which is reserved for investigational medicines where preliminary clinical evidence indicates the potential for substantial improvement over available therapies. A BTD enables greater FDA guidance on an asset’s development programme. The BTD for bepirovirsen builds on the Fast Track Designation also provided by the US FDA in February 2024. A Fast Track Designation expedites the review of drugs to treat serious conditions and fill an unmet medical need.
Read the full press release here.
Source : GSK
Related HIV and Co-Infections News
-
[Report] WHO: Efforts to eliminate hepatitis delivers gains but more action needed to meet 2030 targets
-
Hepatitis B: Updates from Aligos Therapeutics, Arbutus Biopharma Corporation and Precision BioSciences
-
EurekAlert!: Between 2.4 and 4.1 million people estimated to be living with chronic hepatitis B infection in Europe
Get involved
Are you living with HIV/AIDS? Are you part of a community affected by HIV/AIDS and co-infections? Do you work or volunteer in the field? Are you motivated by our cause and interested to support our work?
Subscribe
Stay in the loop and get all the important EATG updates in your inbox with the EATG newsletter. The HIV & co-infections bulletin is your source of handpicked news from the field arriving regularly to your inbox.