Clesrovimab approved by FDA for RSV prevention in infants

View profile for Juan Lama

Chief Scientific Officer, RetroVirox Inc.

Clesrovimab for Prevention of RSV Disease in Healthy Infants - The recently FDA-approved antibody against RSV prevented  RSV-associated hospitalization of infants within 150 days with an efficacy of 84.2%. The antibody also prevented RSV-associated medically attended lower respiratory infections with an efficacy of 60.4% when compared to placebo controls. The Phase 2b-3 trial monitored 3614 infants. 2412 infants were treated with an injection of  clesrovimab  (intramuscular, 105-mg dose), whereas 1202 received placebo. Clesrovimab (Enflonsia, Merck) acts by binding to the prefusion F protein of RSV and  neutralizing virus entry into host cells. The findings suggest that a single-dose of the antibody in healthy preterm and full-term infant can be used to reduce  the incidence of RSV-associated lower respiratory infections and  hospitalizations. https://sco.lt/8KqIbo #RSV #clesrovimab #Enflonsia #FDA #CDC #WHO #NIH #NIAID #ECDC  #health #globalhealth #publichealth #medicine #Enantapharmaceuticals #clinicaltrials

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Conrrad Nicholls, PhD, MPH

Associate Director of Virology - Eradivir - Former D1 Athlete - Passionate about all things biotech

1w

Really appreciate you highlighting this milestone! The CLEVER trial results showing 84.3% efficacy against hospitalizations with a simple weight-independent 105 mg dose represent both strong clinical outcomes and improved operational feasibility for providers. While still a prophylactic treatment, having clesrovimab as an alternative to nirsevimab is strategically important by diversifying supply, potentially improving access, and acts as a backup option should resistance emerge to either agent. While we at Eradivir are competing for a slice of the RSV therapy pie, both prophylactics and post-infection therapeutics (such as ours) are equally important in serving the patient. I'm particularly interested in following the head-to-head comparisons and real-world effectiveness data as both antibody products are deployed this upcoming RSV season!

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