FDA: PDUFA Date Assigned for Arexvy as RSV Prevention in Age 50 to 59


June 7, 2024 is the target PDUFA date for the additional indication of GSK's respiratory syncytial virus vaccine Arexvy.

The FDA has assigned priority review to GSK’s Arexvy and assigned a Prescription Drug User Fee Act date of June 7, 2024, to prevent respiratory syncytial virus (RSV) in adults aged 50 to 59 who are at increased risk. Arexvy (respiratory syncytial virus vaccine, adjuvanted) is currently approved in the United States for adults aged 60 and over for the prevention of lower respiratory tract disease caused by RSV.

Respiratory syncytial virus (RSV) / image credit: dr_microbe - stock.adobe.com

Respiratory syncytial virus (RSV) / image credit: dr_microbe - stock.adobe.com

RSV is a common virus that can lead to potentially serious respiratory illness. Older adults, including those with underlying medical conditions such as diabetes and chronic heart and lung disease, are at increased risk of severe RSV illness and drive the majority of RSV hospitalizations. About 177,000 adults 65 years and older are hospitalized in the United States because of RSV.

The application is supported by results from a phase 3 trial that assessed the immune response in 570 participants aged 50 to 59 with stable chronic diseases. Additionally, a group of 570 participants aged 50 to 59 without these chronic diseases were also evaluated compared with adults aged 60 and older. Data released in October 2023 showed Arexvy in 50-to-59-year-olds met the endpoint of being non-inferior to adults over the age of 60. GSK said in a press release that results from this trial will be presented at upcoming medical conferences and submitted for peer-reviewed publication.

Key Takeaways

  • Arexvy is currently approved for adults aged 60 years and older to prevent lower respiratory tract infections caused by RSV.
  • The additional indication targets use in adults between 50 and 59 years of age at increased risk for RSV.
  • GSK's application is supported by results from a phase 3 clinical trial evaluating the immune response in this patient population.

READ MORE: Vaccine Coverage for Respiratory Viruses Needs to Increase

GSK used a priority review voucher to reduce the FDA review period of this supplemental biologics license application (sBLA) by four months.

Arexvy was approved in May 2023 and was the first RSV vaccine approved. The CDC’s Advisory Committee on Immunization Practices (ACIP) has recommended the use of Arexvy in the over 60 population.

This article originally appeared on Formulary Watch.

1. GSK's RSV vaccine, Arexvy, accepted under priority review in US for the prevention of RSV disease in adults aged 50-59 at increased risk. News release. GSK. February 6, 2024. Accessed February 8, 2024. https://us.gsk.com/en-us/media/press-releases/gsk-s-rsv-vaccine-arexvy-accepted-under-priority-review-in-us-for-the-prevention-of-rsv-disease-in-adults-aged-50-59-at-increased-risk/
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