FDA Advisers Vote in Favor of Infant RSV Drug

AstraZeneca Plc’s and Sanofi’s drug to prevent respiratory syncytial virus won support from a U.S. regulatory panel for use in infants, potentially adding to a group of breakthrough products set to reach pharmacy shelves this year.

The 21 advisers to the Food and Drug Administration voted unanimously on Thursday to endorse the medicine for newborns and infants, calling the treatment’s safety profile compelling.

“The incredible importance of a disease that infects almost every child before the age of two—the impact of that disease on their families, on the children themselves, on the health-care system—all make a product like this very important,” said Douglas Diekema, a temporary advisory committee member and professor of pediatrics at the University of Washington in Seattle. “I was convinced by the efficacy data, I was reassured by the safety data.”

The long-acting monoclonal antibody called Beyfortus is designed to prevent the lung ailment in newborns and infants entering their first RSV season, which runs through the winter months. The drug is a single dose, which could boost uptake and real-world efficacy, committee members said.

Read More: What to Know About RSV in Kids and Babies

The panel also voted 19-2 to support the antibody’s use for children as old as two, who remain vulnerable to the disease through their second RSV season. Sally Hunsberger, a committee member and biostatistician at the National Institutes of Health, said she voted a “weak no” because she wanted to ensure that further research was done on the drug’s use in these populations, which includes those with congenital heart disease.

Recommendations from FDA advisory panels like the Antimicrobial Drugs Advisory Committee aren’t binding but are often followed by the agency. The drug is already approved for use in the U.K., European Union, and Canada.

“We are encouraged by the advisory committee’s positive vote based on the compelling clinical development program supporting nirsevimab and its breakthrough potential to reduce the magnitude of annual RSV burden,” Thomas Triomphe, Sanofi’s executive vice president of vaccines, said in an email.

Iskra Reic, Astra’s executive vice president of vaccines and immune therapies, said in a statement the drug “builds on AstraZeneca’s strong science, leadership in RSV and commitment to addressing the needs of the most vulnerable.”

RSV is the leading cause of hospital admission for babies under the age of one, and most children catch the disease before age two. Scientists and doctors have been looking for vaccines and drugs against RSV, which also creates a large health burden in older people, for more than 60 years.

Two vaccines for the older adult population from GSK Plc and Pfizer Inc. were approved by the FDA last month, and a maternal vaccine from Pfizer aimed at babies is expected to receive clearance this year. The market for RSV vaccines in older adults alone could be worth $10 billion within the next decade, according to Bloomberg Intelligence.

Prior to the recent breakthroughs, Astra had an older drug that was a passive immunization for infants at risk of severe disease from RSV. The antibody provides only short-term protection and requires multiple injections.