RSV is a seasonal virus that hospitalizes tens of thousands of children each year. On Thursday, FDA advisors voted in favor of approval of a long-acting antibody that protects infants from RSV infection.
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Christoph Soeder/Image Alliance via Getty Images
RSV is a seasonal virus that hospitalizes tens of thousands of children each year. On Thursday, FDA advisors voted in favor of approval of a long-acting antibody that protects infants from RSV infection.
Christoph Soeder/Image Alliance via Getty Images
An advisory panel to the U.S. Food and Drug Administration has recommended that the agency approve a new antibody drug to protect infants from the severe lung disease caused by respiratory syncytial virus, also known as RSV.
The panel voted in favor of FDA approval of an injectable antibody drug called nirsevimab on Thursday after hours of testimony from drugmaker AstraZeneca, FDA scientists and the public.
The question before the panel is whether the benefits of treatment outweigh the risks. The drug, if approved, would provide protection to infants from the virus during their first RSV season with just one injection.
The 21-member committee unanimously supported approval of the drug in infants before or during the first RSV season. And, in another vote, all but two of the panel members supported giving the drug to medically at-risk infants during the second RSV season.
RSV is a viral infection that hospitalizes 58,000 to 80,000 young children each year, making it the leading cause of infant hospitalization in the United States
While the FDA is not required to follow recommendations, it usually does. The agency expects to make a decision in the third quarter of 2023.
If approved within that timeframe, the companies say they are ready to launch a preventive vaccine in the U.S. by the 2023-2024 RSV season. The antibody was approved by EU authorities last fall and is currently being considered for use in several Asian countries.
