FDA approves supplement for Merck's Enflonsia (clesrovimab-cfor)
The agency's efficacy supplement for the injectable RSV antibody was approved with a status date of October 14, 2026.
The U.S. Food and Drug Administration approved a supplement to the biologics license application for Enflonsia (clesrovimab-cfor), according to FDA drug approval records. The submission is listed as BLA761432, supplement number 3, with a submission status of approved and a submission status date of 2026-10-14.1
The sponsor of the application is Merck Sharp Dohme. Enflonsia is formulated as an injection solution containing clesrovimab-cfor at a strength of 105MG/0.7ML.1
The supplement was classified by the FDA as an efficacy submission and was given standard review priority rather than priority review, per the agency's records. The review priority for this submission is listed as standard.1
The FDA issued a corresponding approval letter dated October 16, 2026, which is posted on the agency's website. The application documentation includes a letter dated 20261016 tied to application number 761432, submission s003.1
The filing does not specify what change the efficacy supplement covers, such as a new indication, dosing update, or additional clinical data supporting the product's existing authorization. Readers seeking the clinical rationale behind the supplement should consult the full approval letter once available through the FDA's Drugs@FDA database.
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