FDA accepts biologics license application for Merck’s RSV shot
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Key takeaways:
- Clesrovimab is a monoclonal antibody that protects against RSV subtypes A and B.
- The FDA set a PDUFA date for June 10, 2025.
The FDA accepted a biologics license application for Merck’s respiratory syncytial virus immunization, clesrovimab, the company announced Tuesday.
Clesrovimab is a monoclonal antibody (mAb) that protects against RSV subtypes A and B. Merck investigators presented the results of two phase 2b/3 trials at IDWeek in October. Compared with placebo, clesrovimab was 50% effective at preventing acute respiratory infections in infants for up to 6 months after administration. It was 81.3% effective at preventing hospitalization and 91.7% effective at preventing severe medically attended lower respiratory tract infections. One dose of clesrovimab was as effective as five doses of palivizumab, experts told Healio.
The FDA set a prescription drug user fee act date for June 10, 2025.
“Despite recent advances in RSV prevention, unmet needs remain for additional effective interventions to help protect infants and continue to help address the burden RSV places on families and the health care system,” Paula Annunziato, MD, senior vice president of infectious diseases and vaccines clinical research at Merck, said in a press release. “This regulatory milestone, along with promising results from our pivotal studies demonstrating efficacy in the prevention of RSV disease, marks important progress toward our goal of having clesrovimab available in time for the 2025-26 RSV season.”
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