GlaxoSmithKline (NYSE:GSK) has announced preliminary positive results from the phase III trial of its respiratory syncytial virus (RSV) vaccine, Arexvy, in adults aged between 50 and 59. The results were presented at the CDC Advisory Committee meeting on Wednesday. The trial demonstrated that the vaccine could potentially generate an immune response in this age group similar to that in adults aged 60 and above, for whom the vaccine is already approved.
The study was placebo-controlled, observer-blind, and randomized. It demonstrated that Arexvy elicited a non-inferior immune response in adults aged 50 to 59 at increased risk for RSV disease compared to adults aged 60 and above. This met the primary co-endpoint of the trial. The most common adverse events reported were pain, fatigue, and headache.
Arexvy contains recombinant glycoprotein F stabilized in the prefusion conformation (RSVPreF3) and is combined with GSK's proprietary AS01 E adjuvant. It received approval from the US FDA on May 3, 2023, the European Commission in June 2023, and Japan's Ministry of Health, Labour and Welfare in September 2023.
Tony Wood, GSK's Chief Scientific Officer, expressed confidence in Arexvy's potential to protect this demographic at increased risk for RSV lower respiratory tract disease (LRTD). He said that GSK aims to be the first company to submit these data to regulators, with decisions on potential label expansion expected in 2024.
Despite being first to market with an RSV vaccine, GSK expects lower rollout numbers for Arexvy compared to its blockbuster Shingrix vaccine. In August 2023, GSK launched a patent lawsuit against Pfizer (NYSE:PFE), alleging that Pfizer's RSV vaccine, Abrysvo, infringed four of Arexvy's patents. Pfizer has refuted these allegations. The approval of Arexvy arrived just before the 2023-2024 RSV season, aiming at an estimated 80 million older adults in the U.S. The final results from the NCT05590403 trial will be presented at an upcoming medical conference and submitted for peer-reviewed publication.
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