FDA Clears First Monoclonal Antibody for RSV in Infants

The FDA approved Sanofi and AstraZeneca’s Beyfortus (nirsevimab-alip) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

The companies plan to make Beyfortus available in the United States ahead of the upcoming 2023-2024 RSV season.

Jon Heinrichs, Ph.D.

“As the first monoclonal antibody approved to protect all infants through their first RSV season, including those born healthy at term or preterm, or with specific health conditions, Beyfortus addresses a critical 60-year unmet need for protection against RSV disease,” Jon Heinrichs, Ph.D., global head of innovation and emerging science, vaccines for Sanofi, told Formulary Watch.

RSV is the leading cause of hospitalization for U.S. babies in their first year of life. While most babies hospitalized with RSV are born at term and healthy, RSV prevention has been historically limited to infants born premature or with preexisting conditions.

“With Beyfortus’ approval, we are working to shift the paradigm in RSV prevention and protect all infants from this seasonal virus,” Heinrichs said.

“RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” John Farley, M.D., M.P.H., director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press release.

Sanofi has not yet set a price for Beyfortus. Heinrich’s said the company’s goal is to “work closely with payers and authorities to determine an appropriate price point based on cost-effectiveness and implementation in all infants.”

“We expect Beyfortus to be priced similarly to an innovative pediatric vaccine series, in accordance with the value and innovation it delivers,” he added.

Sanofi is working with the CDC Advisory Committee on Immunization Practices (ACIP) to place Beyfortus on the CDC’s childhood vaccines schedule, “as the Affordable Care Act (ACA) generally requires insurance coverage for all immunizations administered in accordance with final CDC recommendations” Heinrichs said. “We also hope to see Beyfortus placed in Vaccines For Children, a federally funded program that provides immunizations at no cost to eligible children who might not otherwise be immunized.”

Sanofi continues to collaborate with ACIP and share the “robust research and evidence demonstrating the potential of Beyfortus to be delivered in a cost-effective, vaccine-like manner,” Heinrichs said.

Related: FDA Committee Recommends Sanofi/AstraZeneca’s RSV Vaccine for Infants

The FDA’s approval follows the positive recommendation of the FDA Antimicrobial Drugs Advisory Committee and was based on the extensive Beyfortus clinical development program spanning three pivotal late-stage clinical trials.

Across all clinical endpoints, a single dose of Beyfortus demonstrated high and consistent efficacy against RSV LRTD extending through five months — a typical RSV season. Beyfortus was well tolerated with a favorable safety profile that was consistent across all clinical trials. The overall rates of adverse events were comparable between Beyfortus and placebo and the majority of adverse events were mild or moderate in severity, according to Sanofi.