FDA panel endorses monoclonal antibodies to prevent viral infection in infants

The following is from MedPage, which is supported by the pharmaceutical industry.

An FDA advisory committee on Thursday gave strong backing to use of a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease (LRTD) in infants as well as in at-risk children up to 24 months of age.

In a unanimous vote, all 21 members of the Antimicrobial Drugs Advisory Committee agreed that the risk-benefit assessment for nirsevimab is favorable for the prevention of LRTD in neonates and infants born during or entering their first RSV season.

Additionally, 19 of 21 members voted that the risk-benefit assessment was favorable for preventing LRTD in kids up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Panelist Karen Kotloff, MD, of the University of Maryland School of Medicine, said she voted yes “because I think that there is a very well-characterized burden of severe disease that needs to be prevented.”

However, Kotloff highlighted several caveats, including that there aren’t enough data to “assess benefit-risk in the kids who are older than 6 to 8 months of age because they had so few events. … It’s really a matter of, is the disease burden sufficient to warrant a recommendation in that age group?”

Panelist Sally Hunsberger, PhD, of the NIH, who voted “no” on the question of risk-benefit assessment in at-risk children up to 24 months of age, said she was “uncomfortable” with relying on extrapolated data to make a decision for this population.

“I worried that if I voted ‘yes,’ then maybe there wouldn’t be quite as much studying done,” Hunsberger said. “So it’s a bit of a weak ‘no,’ but hopefully that will just emphasize that I feel like we do need more more data on this. I think we need to do more studies to totally understand this.”

Nirsevimab is a long-acting RSV fusion protein inhibitor monoclonal antibody delivered via intramuscular injection that was developed by AstraZeneca.

Its proposed indication is prevention of LRTD due to RSV in neonates and infants born during or entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.

RSV causes a significant burden of disease among infants in the U.S. every year, according to AstraZeneca’s presentation to the committee, including about 100 deaths, between 33,000 and 80,000 hospitalizations, 150,000 emergency department visits, 400,000 physician office or clinic visits, and 590,000 medically attended lower respiratory tract infections.

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3 thoughts on “FDA panel endorses monoclonal antibodies to prevent viral infection in infants”

  1. Sharyl this story I think I seriously should show my past new Formulas documented with you and the federal trade commission past filed report complaints and New Medical Chemistry Formulas to FDA about New break through antibodies chemistry discoveries in Chem. Mol.. “Why ? because how can the FDA make good faith future judgments about this and future topic when new chemistry ideas discoveries I made in past, was never revealed to them ( Why didn’t you tell us the FDA about these discoveries examples ? ) See point ? There are other Lab engineered Sub-Units Epitope tag Antibodies Protein Formulas, some I discovered in past that could be engineered in a lab as better answers to this RSV problem in young kids but would have to be tested and tweaked in research Chemistry labs ( You would need multiple people working together to get job done Faster ). Another one involving preventing cancer cells in children I already told you that formula Just don’t let anybody steal that Formula idea..’ The Summit of knowledge is only bound by the energy used to create it ! _ Wm. Andrews Rochester, IN.

  2. My earlier post Discoveries, tell the FDA and CDC the other New answers in better protecting Mitochondrial eukaryotic cell’s is in New Formulas involving Lab engineered Sub- Unit epitope tag proteins _ Wm. Andrews Rochester, IN. Discoverer of New Mass Energy equivlances —> Energy equals subgroups Pi,

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