AstraZeneca today announced positive news regarding Nirsevimab, an investigational long-acting respiratory syncytial virus (RSV) antibody co-developed with Sanofi.
Clinical results from a pre-specified pooled analysis of the pivotal Phase III and Phase IIb MELODY trials showed that nirsevimab demonstrated efficacy (relative risk reduction versus placebo) of 79.5% (95% confidence interval % [CI] 65.9 to 87.7; P
The pooled analysis studied healthy preterm and term infants who received the optimized dose of nirsevimab versus placebo through day 151 and showed an efficacy of 77.3% (95% CI 50, 3; 89.7; P
In a pooled post-hoc analysis separate from the trials, blood samples taken from infants who received nirsevimab showed neutralizing antibodies against RSV that were about 50 times higher than baseline values at day 151 post-dose.
RSV neutralizing antibody levels remained 19 times higher than those of placebo recipients with no known RSV infection through day 361, suggesting that protection may extend beyond day 151.
And the overall safety profile of nirsevimab in both trials has been previously reported, and no clinically meaningful differences in safety outcomes were observed between the nirsevimab and placebo groups.
These test results form the basis for regulatory submissions that began in early 2022.
Mene Pangalos, EVP BioPharmaceuticals R&D, AstraZeneca, said in a Press release published on May 11, 2022, “These analyzes add to the compelling body of evidence for nirsevimab as the first potential single-dose preventive immunization for all infants against RSV, addressing a clear unmet need in the preventive landscape. RSV.”
Nirsevimab has not been approved by any regulatory authority, and the US FDA has not approved any RSV vaccine candidates.
The data is presented at the 40th annual meeting of the European Society for Pediatric Infectious Diseases in Greece.
Direct medical costs related to RSV – including inpatient, outpatient and follow-up care – were estimated at 4.82 billion worldwide in 2017.
Additional news on the development of RSV is posted at PrecisionVaccinations.com/RSV.
Note: The AZ press release was selected and edited manually for mobile readers.