GSK received the first approval from the Food and Drug Administration for a respiratory syncytial virus (RSV) vaccine, marking a major development in the increasingly competitive RSV space.
Arexvy, GSK’s vaccine, is now approved to be administered to adults over the age of 60 to protect from RSV infection.
GSK’s approval was based on the strength of its Phase 3 trial data, which were published in the New England Journal of Medicine (NEJM) and showed a vaccine efficacy of 94% against severe disease.
Earlier this spring, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of Arexvy’s effectiveness and 10 to 2 in favor of its safety profile.
The British pharma giant said it intends to launch Arexvy prior to the start of the 2023/24 RSV season this fall.
“Today marks a turning point in our effort to reduce the significant burden of RSV. Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year,” GSK’s chief scientific officer Tony Wood said in a statement. “Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.”
Between the VRBPAC vote and FDA approval, GSK wasted no time promoting its RSV capabilities and highlighting concerns around the disease.
The company brought in NBA Hall of Famer Earvin “Magic” Johnson for its Sideline RSV campaign to raise awareness about the seriousness of the disease as well as how older people can prevent infection.
The regulatory greenlight gives GSK a leg up among its closest competitors, Moderna and Pfizer, in the RSV vaccine area.
Moderna’s vaccine, mRNA-1345, received a breakthrough designation from the FDA at the end of January and the biotech plans to file a license application for regulatory approval in the first half of the year.
Meanwhile, though Pfizer’s vaccine did not receive as much support in the form of votes from VRBPAC, the company recently published two articles highlighting its Phase III RSV data in NEJM.
