The FDA voted unanimously to endorse the long-acting monoclonal antibody Beyfortus for newborns and infants.
straZeneca 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 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.
“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. 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, which also creates a large health burden in older people, for more than 60 years.
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