- In March 2024, Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy (tenofovir alafenamide) 25 mg tablets, allowing it to be used as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients aged six years and older, weighing at least 25 kg, and with compensated liver disease.
- In February 2024, Vaxelis, a pediatric hexavalent (six-in-one) combination vaccine, has been available in the USA since 2018 and in Europe. The U.S. FDA granted a Supplemental Approval on April 12, 2023, and has released an updated Package Insert and Patient Information. Vaxelis was developed through a partnership between Merck and Sanofi Pasteur, which was established in 1991.
- In February 2024, GSK plc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to bepirovirsen, an investigational antisense oligonucleotide (ASO) aimed at treating chronic hepatitis B (CHB). This designation is designed to accelerate the development and review process for drugs addressing serious conditions and unmet medical needs.
- In June 2023, Vir Biotechnology, Inc. announced new data from its comprehensive hepatitis B and D virus (HBV and HDV) portfolio, presented at the EASL (European Association for the Study of the Liver) Congress. A late-breaking oral presentation from a Phase 2 clinical trial revealed that when VIR-2218, an investigational small interfering ribonucleic acid (siRNA), was administered for 24 or 48 weeks alongside up to 48 weeks of pegylated interferon alpha (PEG-IFN-⍺) (combined cohorts 4 and 5), 16% (5/31) of patients achieved sustained HBsAg loss 24 weeks after treatment ended.
- In September 2022, Valneva SE and VBI Vaccines Inc. announced a partnership to market and distribute PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)] in select European markets. PreHevbri is the only 3-antigen hepatitis B vaccine approved in Europe.
