- GSK plc (NYSE:GSK) intends to engage with regulators immediately after reporting positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial, it anticipates regulatory submissions in the second half of 2022.
- AReSVi 006 is a phase III trial investigating GSK’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above.
- An Independent Data Monitoring Committee reviewed the interim analysis, and the primary endpoint was exceeded with no unexpected safety concerns observed.
- GSK’s RSV OA vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01 adjuvant. The antigen plus adjuvant combination may help overcome the natural age-related decline in immunity that contributes to the challenge of protecting older adults from RSV disease.
- Also Read: FDA Approves GSK’s Measles Vaccine
- “These data suggest our RSV vaccine candidate offers exceptional protection for older adults from the serious consequences of RSV infection. RSV remains one of the few major infectious diseases without a vaccine, and these data have the potential to meaningfully impact the treatment of RSV and may reduce the 360,000 hospitalizations and more than 24,000 deaths worldwide each year,” commented Dr. Hal Barron, Chief Scientific Officer, and President, R&D, GSK.
- Price Action: GSK shares are trading higher by 0.60% at $43.30 during the premarket session on Friday.
