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

The Food and Drug Administration’s (FDA) Antibiotics Advisory Committee on Thursday voted unanimously in favor of approval of an RSV drug for infants, following the overwhelming surge in RSV cases seen in infants last year. Close to product approval.

All 21 members of the FDA’s Antimicrobial Advisory Committee (AMDAC) who attended the meeting “agreed” when asked whether a comprehensive benefit-risk assessment of the drug nircevimab would be beneficial in preventing respiratory syncytial virus infection. and voted.

Mary Ann Jackson, dean of medicine at the University of Missouri, Kansas City, said she voted in favor because of the need for such a drug, and said she was convinced by a presentation made during the conference.

“We have excellent immunization-based data, safety data, and excellent efficacy data showing that this product prevents a significant number of cases of RSV lower respiratory tract disease,” Jackson said.

Last winter, a surge in RSV infections among infants led to a shortage of beds in many hospitals. Experts attribute the surge to the coronavirus lockdown, which leaves many babies and toddlers free of respiratory syncytial virus, commonly known as “nursery school disease.”

The drug discussed Thursday, nircevimab, is a monoclonal antibody developed by AstraZeneca and marketed by Sanofi. The proposed use of the drug would be in infants born during or entering her first RSV season and would be administered as a single dose.

“Nirsevimab builds on AstraZeneca’s strong science, leadership in respiratory syncytial virus and commitment to addressing the needs of the most vulnerable,” said Iskra Reich, Executive Vice President, Vaccines and Immunotherapy, AztraZeneca, in a statement. Stated.

“We look forward to continuing to work with the FDA to complete an expedited review and, given the significant burden of RSV in infants, we hope that nilcevimab will be available as soon as possible. .”

Monoclonal antibodies are also used to treat RSV infection in infants after symptom onset, but this option is usually reserved for very high-risk cases. The vote came shortly after the FDA approved the first RSV vaccine for the elderly.