Sanofi launches Beyfortus® (nirsevimab-alip) Reservation Program for 2024-2025 RSV season in U.S.

Bridgewater, N.J., February 1, 2024. Sanofi continues to engage with its manufacturing partner AstraZeneca, government officials, healthcare providers and others in the U.S. to help ensure available Beyfortus® (nirsevimab-alip) 50mg and 100mg Injection doses reach eligible babies for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease.

Currently, insurance coverage is in place for nearly 100% of infant lives in the U.S. To help facilitate ongoing access to available doses for eligible babies, Sanofi continues to work closely with providers in the private market and the Vaccines for Children (VFC) program to best support the communities they serve. Nearly 40% of eligible babies could have the ability to be immunized against RSV with Beyfortus this RSV season.

Knowing the critical role providers have in helping to protect as many babies as possible from RSV, Sanofi has established the Beyfortus Reservation Program to further strengthen customer collaboration in support of improved readiness for the 2024-2025 RSV season. The Beyfortus Reservation Program provides critical insight on customer demand and allows for prioritized fulfillment of requests placed through this program. It offers providers   flexibility in scheduling shipments and the ability to cancel orders within terms.

Ayanna Santos, Pharm.D.
Head of RSV Franchise, U.S. Vaccines, Sanofi
“We are focusing on how we partner with customers with the aim of protecting babies from the leading cause of infant hospitalization in the U.S. We’re excited by the potential of the Beyfortus Reservation Program to help support planning for the next RSV season.” 

For those who order outside of the Beyfortus Reservation Program, the normal order window will be available from September 2024 through February 2025. The Beyfortus Reservation Program is not applicable to the VFC program, and Sanofi continues to engage with the Centers for Disease Control and Prevention to ensure supply for the VFC program. Providers should consult their state or local VFC program to order Beyfortus for their VFC patients for the 2024-2025 season.

Beyond the Beyfortus Reservation Program for the private market, Sanofi is also taking additional measures to help ensure greater preparedness for the 2024-2025 season. Sanofi will continue to work with AstraZeneca to expand the Beyfortus manufacturing network to allow for a significant increase in supply for the 2024-2025 season and cover the entire U.S. demand. Beyfortus is being manufactured well in advance of the RSV season, with the vast majority of doses expected to be available before October.

For private customers who are interested in participating in the Beyfortus Reservation Program, they should contact their Sanofi representative or request a representative at Beyfortus.com.

Sanofi appreciates its ongoing collaboration with government agencies and looks forward to working with providers to reach our shared ambition to protect as many babies as possible against RSV.

INDICATION

Beyfortus is a prescription medicine used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV) in:

  • Newborns and babies under 1 year of age born during or entering their first RSV season.
  • Children up to 24 months of age who remain at risk of severe RSV disease through their second RSV season.

IMPORTANT SAFETY INFORMATION

Your child should not take Beyfortus if your child has a history of serious allergic reactions to nirsevimab-alip or any of the ingredients in Beyfortus.

Before your child receives Beyfortus, tell your healthcare provider about all of your child’s medical conditions, including if your child:

  • has ever had a reaction to Beyfortus.
  • has bleeding or bruising problems. If your child has a problem with bleeding or bruises easily, an injection could cause a problem.

Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your infant should not receive a medicine called palivizumab if they have already received Beyfortus in the same RSV season.

Serious allergic reactions have happened with other medicines like Beyfortus. Get medical help right away if your child has any of the following signs or symptoms of a serious allergic reaction:

  • swelling of the face, mouth, or tongue
  • difficulty swallowing or breathing
  • unresponsiveness
  • bluish color of skin, lips, or under fingernails
  • muscle weakness
  • severe rash, hives, or itching

The most common side effects of Beyfortus include rash and pain, swelling, or hardness at the site of your child’s injection. These are not all the possible side effects of Beyfortus. Call your healthcare provider if you have questions about side effects.

Please see full Prescribing Information, including Patient Information for more details.

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com

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