FDA Decisions to Watch Q1-Q2: Infectious Disease

CHIKV VLP

PDUFA Date: 2/14/2025

Company: Bavarian Nordic

The CHIKV VLP vaccine is a single-dose vaccine aimed at preventing chikungunya virus, which is transmitted by mosquitoes and can cause fever and debilitating joint pain. If approved, this will be the first and only VLP-based vaccine for chikungunya available in the US The vaccine is being developed for adults aged 12 and older.¹

ABCWY (MenABCWY)

PDUFA Date: 2/14/2025

Company: GSK

ABCWY is a vaccine for invasive meningococcal disease, protecting against multiple strains of Neisseria meningitidis. It is designed for primary care and pediatric populations to prevent serious, potentially fatal infections like meningitis and septicemia caused by this bacteria.²

MenQuadfi Vaccine

PDUFA Date: 3/25/2025

Company: Sanofi

MenQuadfi is a vaccine for the prevention of meningococcal disease in pediatric populations. It targets multiple strains of Neisseria meningitidis, the bacteria responsible for meningitis and other severe diseases. The vaccine is intended to help protect children from these life-threatening infections.³

Gepotidacin

PDUFA Date: 3/26/2024

Company: GSK

Gepotidacin is an antibiotic for the treatment of uncomplicated urinary tract infections (UTIs) in adult women. It offers a novel mechanism of action and represents a potential new treatment option, especially in cases where resistance to standard antibiotics is an issue.⁴

Tesamorelin F8

PDUFA Date: March 2025 (Exact date TBD)

Company: Theratechnologies

Tesamorelin F8 is a growth hormone-releasing factor used to reduce excess abdominal fat in adults living with HIV and lipodystrophy. After receiving a Complete Response Letter (CRL) in January 2024 due to manufacturing concerns, Theratechnologies resubmitted the sBLA for review in late 2024, addressing issues related to chemistry, manufacturing, and controls.⁵

Novavax COVID-19 Vaccine

PDUFA Date: April 2025

Company: Novavax

The Novavax COVID-19 vaccine is a protein-based vaccine that has received Emergency Use Authorization (EUA) and is now seeking full approval for use in preventing COVID-19 infections. It offers an alternative to mRNA-based vaccines and is aimed at individuals who prefer a more traditional vaccine platform.⁶

Clesrovimab

PDUFA Date: June 10, 2025

Company: Merck

Clesrovimab is a monoclonal antibody aimed at protecting infants from RSV, has been accepted by the FDA. If approved, it will be the first single-dose immunization for infants, regardless of weight, offering protection throughout their first RSV season.⁷

Zoliflodacin

PDUFA Date: Q1 2025 (Exact date TBD)

Company: Innoviva Specialty Therapeutics

Zoliflodacin is an antibiotic being developed to treat gonorrhea, particularly against strains resistant to other antibiotics. It is a potential new option for treating this sexually transmitted infection, which has become increasingly difficult to treat due to antimicrobial resistance.⁸

References

1. Bavarian Nordic. Bavarian Nordic announces FDA acceptance and priority review of the BLA for its chikungunya vaccine. PDUFA target action date of February 14, 2025. August 13, 2024. Accessed January 28, 2025. https://www.bavarian-nordic.com/investor/news/news.aspx?news=6967

2. GSK. GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA. Issued April 16, 2024. Published in London, UK. Accessed January 28, 2025. https://www.gsk.com/en-gb/media/press-releases/gsk-s-5-in-1-meningococcal-abcwy-vaccine-candidate-accepted-for-regulatory-review-by-us-fda/

3. Theratechnologies. Theratechnologies submits updated tesamorelin F8 formulation sBLA for FDA review. Business Wire. November 26, 2024. Accessed January 27, 2025. https://www.theratech.com/news-releases/news-release-details/theratechnologies-submits-updated-tesamorelin-f8-formulation

4. GSK. Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents. October 16, 2024. Accessed January 28, 2025. https://www.gsk.com/en-gb/media/press-releases/gepotidacin-accepted-for-priority-review-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections-in-female-adults-and-adolescents/

5. Theratechnologies Inc. Theratechnologies receives March 2025 PDUFA goal date for updated tesamorelin F8 formulation sBLA. December 10, 2024. Accessed January 28, 2025. https://www.theratech.com/news-releases/news-release-details/theratechnologies-receives-march-2025-pdufa-goal-date-updated

6. Novavax. Novavax continues to partner with the U.S. FDA on review of 2024-2025 formula COVID-19 vaccine. Updated August 23, 2024. Accessed January 28, 2025. https://ir.novavax.com/press-releases/Novavax-Continues-to-Work-with-the-US-FDA-on-Authorization-of-2024-2025-Formula-COVID-19-Vaccine

7. GARDP. Request for Proposal for Managed Access Program for Zoliflodacin. Closing date: November 20, 2023. Accessed January 28, 2025. https://gardp.org/rfp/gardp-request-for-proposal-for-managed-access-program-for-zoliflodacin/

8. Merck. Merck announces FDA acceptance of Biologics License Application for clesrovimab, an investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season. Business Wire. December 17, 2024. Accessed January 27, 2025. https://www.merck.com/news/merck-announces-fda-acceptance-of-biologics-license-application-for-clesrovimab-an-investigational-long-acting-monoclonal-antibody-designed-to-protect-infants-from-rsv-disease-during-their-first-rsv/