RSVpreF

The FDA has called out Sanofi’s promotion of respiratory syncytial virus (RSV) antibody Beyfortus in a new untitled letter, taking issue with the company’s characterization of the med as a general RSV preventative. As the FDA explains in the letter (PDF), Beyfortus’ 2023 U.S. approval specifically clears the drug as a defense against RSV lower respiratory tract disease. Sanofi’s promotional emails (PDF) regarding Beyfortus, on the other hand, urge healthcare professionals to “help prevent RSV disease in infants,” creating what the FDA’s Office of Prescription Drug Promotion (OPDP) deems a “misleading impression” about the drug’s indication. Specifically, the Sanofi emails seem to point to Beyfortus' use as a general RSV preventative, “including both upper and lower respiratory tract disease, when this is not the case,” the FDA explained. In its promotional emails (PDF) flagged by the FDA, the company refers to Beyfortus as a monoclonal antibody to help prevent “RSV disease” numerous times. Although Sanofi does mention Beyfortus’ official indication to prevent RSV lower respiratory tract infection further down in the emails—and also notes the indication in full in its ‘indication’ section—the agency maintains that the “presentation of this information is not sufficient to correct the overall misleading impression created by these claims.” The letter asks that Sanofi take “immediate action” to address the concerns and submit a written response within 15 working days from the date of receipt. A Sanofi spokesperson acknowledged the untitled letter in an emailed statement to Fierce Pharma Marketing, noting that the company takes “this matter seriously" and is "reviewing the letter carefully.” “Sanofi maintains strict regulatory compliance policies for its promotional communications. We are committed to ensuring that all promotional materials for Beyfortus are accurate, balanced, and fully compliant with FDA regulations. We will respond to the agency within the required timeframe,” the spokesperson added. The new OPDP letter, released to the public on July 22 and dated July 15, comes as the company faces separate marketing backlash in the U.K. from the country's drug marketing watchdog, the PMCPA. On July 21, the PMCPA hit Sanofi with a public reprimand for “very serious breaches” of the Association of the British Pharmaceutical Industry (ABPI) code based on its Beyfortus claims across the pond. The case goes back to a 2024 article in which Sanofi’s former CEO Paul Hudson was quoted saying that the U.K.'s national RSV vaccine program should consider Beyfortus instead of Pfizer’s Abrysvo, which led Pfizer to contact the PMCPA over the article and two others, plus a press release. Sanofi could still face further sanctions over the matter in the U.K. and is to provide the PMCPA with a copy of a third-party audit report it has arranged for. The high level of regulatory scrutiny over the case stems from the PMCPA’s conclusion that the company’s claims could “undermine the public’s trust in vaccination campaigns” and spark decreasing vaccine rates and public health concerns. Last year, Sanofi’s global Beyfortus sales totaled 1.78 billion euros ($2.03 billion), representing 5.6% growth from 2024. The company co-developed the med with AstraZeneca and brought it to the U.S. market in July 2023. The duo shares the RSV-LRTI prevention market with Merck and its Enflonsia , while Pfizer’s Abrysvo can be used as a maternal vaccine in pregnant women to prevent RSV in children from birth.