FDA approves Merck’s Enflonsia
The US Food and Drug Administration (FDA) has approved Enflonsia (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season, US pharma giant Merck & Co (NYSE: MRK) revealed yesterday.
Enflonsia is a preventive, long-acting monoclonal antibody (MAb) designed to provide direct, rapid and durable protection through five months, a typical RSV season, with the same 105mg dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year.
The green light sets up a head-to-head commercial showdown with Sanofi (Euronext: SAN) and AstraZeneca's (LSE: AZN) preventive antibody Beyfortus (nirsevimab-alip).The approval came just hours after Sanofi announced it would accelerate shipments of Beyfortus globally ahead of the upcoming season.
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