GSK Builds Combo Case for RSV, Shingles Shots With Phase III Data

 

If approved, the co-administration of Arexvy and Shingrix could provide a more convenient vaccination regimen for patients and potentially bolster GSK’s faltering sales for both vaccines.

GSK on Wednesday unveiled promising topline Phase III data for a combo regimen of its RSV vaccine Arexvy and shingles shot Shingrix, touting a comparable immunogenicity profile to the individual vaccines.

The company did not provide specific data in its announcement, only noting that co-administering Arexvy with Shingrix resulted in a “non-inferior immune response” compared with inoculation with the vaccines at separate visits. The vaccine combo was also well-tolerated with an “acceptable” safety profile, according to GSK, though it’s not clear if there were more side effects after co-administration of the shots.

“With our co-administration studies, GSK is using its science and technology to help remove barriers to adult immunization, by potentially reducing the number of visits to the healthcare offices and pharmacies and ultimately help to get ahead of RSV and shingles,” Led Friedland, GSK’s vice president of scientific affairs and public health, said in a statement.

GSK will use these Phase III data to build a regulatory case for the co-administration of Arexvy with Shingrix, which, if approved, could help the company shore up sales for these products. The company plans to file submissions with the FDA and the European Medicines Agency, according to the announcement.

Arexvy is the clear leader in the RSV vaccine space, becoming the first approved shot in May 2023, a month ahead of its closest competitor, Pfizer’s Abrysvo. In its third-quarter 2023 earnings report, GSK announced that Arexvy accounted for two-thirds of all retail vaccinations in the U.S., bringing in $859 million in its first full commercial quarter.

In a December 2023 interview with Reuters, GSK CEO Emma Walmsley said that she expects Arexvy to hit blockbuster status. The company took a big step toward this goal in June 2024, when the FDA signed off on the use of Arexvy in younger seniors aged 50 to 59 years.

However, that same month, the CDC’s Advisory Committee on Immunization Practices narrowed its RSV guidelines, raising its recommended vaccination age from 60 to 75 years. In the age group of 60 to 74 years, only those who are at risk of developing severe disease are advised to get the shot. These changes could stymie the growth of Arexvy.

Meanwhile, GSK’s shingles vaccine Shingrix has more than exceeded the blockbuster mark, bringing in over $4.3 billion in 2023 and contributing heavily to the 25% growth in the company’s vaccine business. However, sales have been slowing. In the second quarter of this year, GSK reported that Shingrix sales dropped 4% year-over-year, due in large part to a new Medicare rule that changed how pharmacies process reimbursements.

https://www.biospace.com/drug-development/gsk-builds-combo-case-for-rsv-shingles-shots-with-phase-iii-data