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ViiV Healthcare Receives FDA Approval for Tivicay PD for Pediatric Use

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, announced that the U.S. FDA has approved Tivicay PD, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric patients weighing at least 2 kg. The FDA approval follows Priority Review for this population and is supported by data from the National Institutes of Health-funded IMPAACT 2023 study and pharmacokinetic modelling incorporating additional paediatric data. These data showed that DTG, a second-generation INSTI with a higher barrier to resistance than previous generations, reached therapeutic drug levels in term neonates with a safety profile consistent with that established in older paediatric and adult populations.

GSK Receives Approval for Hibsago as Functional Cure for Chronic Hepatitis B in Japan

GSK announced that Japan's Ministry of Health, Labour and Welfare, MHLW, has approved Hibsago, an antisense oligonucleotide, ASO, as a functional cure for chronic hepatitis B, CHB, virus infection in adult patients who have received at least 6 months of prior nucleos(t)ide analogue therapy and meet pre-defined viral markers. This is the first global approval for bepirovirsen, and the first and only functional cure treatment for CHB approved in Japan. Approval in Japan was supported by results from the B-Well phase III trials showing unprecedented functional cure rates of 19% in adults with less than or equal to 3000 IU/ml HBsAg, compared to current standard of care alone which typically only achieves a 1% functional cure rate after one year of treatment.

GSK's Jemperli Receives FDA Priority Review

GSK announced the US Food and Drug Administration, FDA, has accepted for priority review a supplemental Biologics License Application, sBLA, for Jemperli for patients with previously untreated stage II and III mismatch repair deficient/microsatellite instability-high locally advanced rectal cancer. The FDA has assigned a PDUFA action date of February 2027. The application is also eligible for expedited review through the National Priority Voucher program, which could result in an earlier FDA decision. The application is based on positive data from the registrational phase II, single-arm AZUR-1 trial, which met its primary objective by demonstrating a meaningful and sustained clinical complete response rate for 12 months with no detectable signs of cancer for at least one year.