FDA panel unanimously votes in favor of RSV antibody treatment for infants

The Food and Drug Administration’s (FDA) antimicrobial drug advisory panel on Thursday voted unanimously in favor of approving a respiratory syncytial virus (RSV) treatment for infants, bringing the product closer to approval following the overwhelming surge in RSV cases that were seen last year in young children.

All 21 members of the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) who were present for the meeting voted “yes” on the question of whether the drug nirsevimab had an overall benefit-risk assessment that was favorable for preventing RSV infections.

Mary Anne Jackson, dean of the University of Missouri-Kansas City School of Medicine, said she voted yes because there is a need for such a medicine, and she was assured by the presentations given during the meeting.

“There is good immune-based data, there’s good safety data and there’s good efficacy data that shows that the product will prevent a significant number of cases of RSV lower respiratory tract disease,” Jackson said.

RSV cases skyrocketed last winter among infants, leaving many hospitals running out of beds. Experts attributed the surge to many infants and young children not being exposed to RSV, known as a common “day care disease,” due to COVID lockdowns.

The drug discussed on Thursday, nirsevimab, is a monoclonal antibody developed by AstraZeneca and marketed by Sanofi. The proposed use for the drug is for infants born during or entering into their first RSV season, and it would be administered as one shot.

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

“We look forward to continuing to work with the FDA to complete their expedited review, and we hope to see nirsevimab available as soon as possible given the significant burden of RSV in infants.”

Monoclonal antibodies are also used to treat RSV infections in infants after they occur, though this option is usually reserved for extremely high-risk cases. This vote comes shortly after the FDA approved the first RSV vaccine for use among older adults.