Sanofi Starts Shipping BEYFORTUS® in US to Protect Babies from RSV; FDA Approves New Manufacturing Line

Sanofi has announced the shipment of BEYFORTUS (nirsevimab-alip) 50mg and 100mg Injection doses to private healthcare providers and the Centers for Disease Control and Prevention (CDC) in the United States. This initiative is part of Sanofi's effort to ensure the availability of BEYFORTUS ahead of the respiratory syncytial virus (RSV) season. BEYFORTUS, a long-acting monoclonal antibody, has been approved for preventing RSV lower respiratory tract disease (LRTD) in newborns and infants during their first RSV season, as well as in children up to 24 months who are at risk of severe RSV disease during their second RSV season.

Thomas Grenier, Head of Vaccines for North America at Sanofi, expressed pride in making BEYFORTUS available to protect every eligible baby in the U.S. during the upcoming RSV season. He credited the achievement to the collaboration with the White House, the CDC, the U.S. Food and Drug Administration (FDA), and healthcare providers. Grenier emphasized the importance of equitable access to BEYFORTUS and highlighted the upcoming season as an opportunity to extend the antibody's protection to as many infants as possible.

Sanofi, in partnership with AstraZeneca, which leads the development and manufacturing of BEYFORTUS, has already produced and packaged doses on a newly approved FDA filling line. This new line is set to increase supply for the Northern Hemisphere's 2024/2025 RSV season, spanning from November to March. Additionally, another filling line is anticipated to contribute to the production capacity for the same season. Sanofi and AstraZeneca are working continuously to build inventory for current and future RSV seasons.

To further ensure preparedness for the RSV season, Sanofi has launched the BEYFORTUS Reservation Program. This program provides insights into the demand from private healthcare providers and allows for prioritized fulfillment of requests. The company is also collaborating with government agencies, including the White House's Office of Pandemic Preparedness and Response Policy, to enhance readiness. Private customers interested in ordering BEYFORTUS doses are encouraged to contact their Sanofi representative or request assistance through BEYFORTUS.com.

RSV is a highly contagious virus that can cause severe respiratory illness in infants. Statistics show that two out of three infants are infected with RSV during their first year of life, and nearly all children are infected by their second birthday. While RSV typically results in mild, cold-like symptoms, it is the leading cause of lower respiratory tract disease, such as bronchiolitis and pneumonia, in infants. RSV LRTD is also the primary reason for hospitalizations in babies under one year old, with most cases occurring in healthy, term-born infants. In the U.S., approximately 590,000 RSV cases in babies under one year old require medical attention annually, including visits to physicians, urgent care, emergency rooms, and hospitalizations.

BEYFORTUS is designed as a single-dose long-acting antibody to prevent RSV LRTD in infants for up to five months, covering the typical RSV season in the U.S. An additional dose is recommended for children undergoing cardiac surgery who are stable post-surgery. Another dose is also indicated for children up to 24 months of age who are still at risk of severe RSV disease through their second RSV season.

The long-acting antibody in BEYFORTUS provides immediate protection against RSV without needing to activate the immune system. Its administration is timed to coincide with the RSV season. BEYFORTUS has received approval for use in the U.S., the European Union, China, Japan, and several other countries. Various regulatory agencies have granted special designations to facilitate its expedited development, including Breakthrough Therapy Designation and Fast Track Designation from the FDA.

BEYFORTUS is a prescription medicine used to prevent serious lung disease caused by RSV in newborn babies and children under 24 months who are at risk of severe RSV disease. However, it is not suitable for children with a history of severe allergic reactions to nirsevimab-alip or any of its ingredients. Parents should inform their healthcare providers about any medical conditions their child has, especially those related to bleeding or bruising, and any medications their child is taking. Serious allergic reactions can occur with BEYFORTUS, and immediate medical help should be sought if symptoms such as swelling, difficulty swallowing, unresponsiveness, or severe rash occur.

Common side effects of BEYFORTUS include rash and reactions at the injection site. Parents are advised to consult their healthcare provider if they have any concerns about side effects.