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GSK-News
GSK-Events
ViiV Healthcare Releases Long-Term Study on Cabenuva Efficacy
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, announced evidence from the OPERA observational cohort spanning five years of real-world use of Cabenuva for HIV treatment in the U.S. and offering important insights into long-term clinical outcomes for adults living with HIV-1. The study evaluated treatment durability - defined as maintaining viral suppression over time - and persistence, defined as remaining on therapy in routine care. In HIV care, durability and persistence are important clinical measures to help protect long-term health and prevent drug resistance. Among virologically suppressed adults in the United States who switched from oral antiretroviral therapy to CAB+RPV LA, after a median treatment duration of 18 months, the data highlight the sustained effectiveness of the long-acting injectable regimen for HIV treatment.
GSK Receives FDA Approval for Hibsago to Treat Chronic Hepatitis B
Ionis Pharmaceuticals (IONS) partner GSK (GSK) announced that the FDA has approved Hibsago for the treatment of chronic hepatitis B, or CHB, virus infection in combination with nucleoside analogue reverse transcriptase inhibitor therapy in adult patients without cirrhosis, receiving NrtI therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid, and with hepatitis B virus surface antigen levels =of 000 IU/ml, as determined by an FDA-authorized test. GSK licensed bepirovirsen from Ionis and collaborated with them on its development.
GSK's Hibsago Approved by FDA for Chronic Hepatitis B Treatment
GSK "announced that the FDA has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B, CHB, virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid, and with hepatitis B virus surface antigen ( levels less than or equal to3000 IU/ml, as determined by an FDA-authorised test. Bepirovirsen is a first-in-class antisense oligonucleotide and offers unprecedented functional cure rates compared to current standard of care. The approval was granted under FDA Priority Review and Breakthrough Therapy Designation, recognizing significant improvement of bepirovirsen and nucleos(t)ide analog therapy over existing standard of care."
GSK's Jemperli Receives FDA Accelerated Approval for Advanced Rectal Cancer
GSK announced the U.S. FDA has approved Jemperli as the first and only immunotherapy for adults with stage II and III microsatellite instability-high/mismatch repair deficient locally advanced rectal cancer under the accelerated approval pathway. Jemperli has received FDA Fast Track and Breakthrough Therapy designations for this indication. The application was also granted Priority Review and received a National Priority Voucher, resulting in an accelerated approval ahead of the PDUFA date.
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