FDA Gears Up for Key Decisions on Vaccines and Novel Therapies in H1 2025
Key Insights
The FDA is set to decide on Bavarian Nordic's CHIKV VLP vaccine (search) for chikungunya (search), potentially the first VLP-based option in the U.S.
GSK's ABCWY vaccine (search), targeting multiple strains of Neisseria meningitidis (search), awaits FDA decision for primary care and pediatric use.
Innoviva Specialty Therapeutics (search)' zoliflodacin, a novel antibiotic for gonorrhea (search), is under FDA review amid rising antimicrobial resistance.
The U.S. Food and Drug Administration (FDA) is poised to make several critical decisions in the first half of 2025 regarding new vaccines and therapies for infectious diseases. These potential approvals could significantly impact the treatment and prevention of diseases ranging from chikungunya (search) to antibiotic-resistant gonorrhea (search).
Vaccines Against Emerging and Existing Threats
Bavarian Nordic's CHIKV VLP vaccine (search), with a PDUFA date of February 14, 2025, is a single-dose vaccine designed to prevent chikungunya (search) virus, a mosquito-borne illness causing fever and severe joint pain. If approved, it would be the first and only VLP-based vaccine for chikungunya available in the U.S., indicated for adults aged 12 and older.
GSK's ABCWY vaccine (search), also with a PDUFA date of February 14, 2025, targets invasive meningococcal disease (search), protecting against multiple strains of Neisseria meningitidis (search). This vaccine is intended for primary care and pediatric populations to prevent serious infections like meningitis and septicemia.
Sanofi's MenQuadfi vaccine, with a PDUFA date of March 25, 2025, is another vaccine aimed at preventing meningococcal disease (search) in pediatric populations, targeting multiple strains of Neisseria meningitidis (search).
Novavax's COVID-19 (search) vaccine is seeking full approval in April 2025 after receiving Emergency Use Authorization (EUA). This protein-based vaccine offers an alternative to mRNA vaccines for individuals preferring a more traditional platform.
Addressing Antibiotic Resistance
GSK's gepotidacin, with a PDUFA date of March 26, 2024, is an antibiotic for uncomplicated urinary tract infections (search) (UTIs) in adult women. It features a novel mechanism of action, offering a potential new treatment option, especially where resistance to standard antibiotics is a concern.
Innoviva Specialty Therapeutics (search)' zoliflodacin is under review for treating gonorrhea (search), particularly strains resistant to other antibiotics. This drug represents a potential new option for this sexually transmitted infection, which has become increasingly difficult to treat due to antimicrobial resistance. The exact PDUFA date in Q1 2025 is yet to be determined.
Therapies for Specific Populations
Theratechnologies' tesamorelin F8 (search) is a growth hormone-releasing factor used to reduce excess abdominal fat in adults living with HIV (search) and lipodystrophy. After a Complete Response Letter (CRL) in January 2024, Theratechnologies resubmitted the sBLA, addressing manufacturing concerns, with a PDUFA date in March 2025.
Merck (search)'s clesrovimab, with a PDUFA date of June 10, 2025, is a monoclonal antibody for preventing and treating COVID-19 (search) in pediatric patients, designed to offer protection and therapeutic benefits for high-risk children.