Will Europe Lead RSV Prevention
Recent news out of Paris indicates a much anticipated Respiratory Syncytial Virus (RSV) prevention treatment for children may soon gain European regulator approval. Moreover, this innovative vaccine-like RSV treatment could become a financial blockbuster.
On September 16, 2022, the European Medicines Agency (EMA) confirmed its Committee for Medicinal Products for Human Use (CHMP) granting marketing authorization for Beyfortus® (nirsevimab) for the prevention of RSV lower respiratory tract infections (LRTI) in newborns and infants during their first RSV season, when there is a risk of RSV infection in the local community.
If approved, Beyfortus would be the first and only single-dose passive immunization for an extensive infant population.
This news is vital since, currently, there is no preventative option available for all infants, and treatment is limited to symptomatic relief.
Beyfortus® is being developed jointly by France-based Sanofi and England-based AstraZeneca.
Jon H. Heinrichs, Ph.D., Global Head, Innovation & Emerging Sciences, Global Project Head, R&D at Sanofi, informed Precision Vaccinations on September 17, 2022, "For decades, the scientific community has worked to develop new options for RSV prevention, which is currently limited to infants with preexisting conditions."
"Unfortunately, this leaves many infants unprotected."
"We're excited by the CHMP's recommendation for Beyfortus as a potential option to protect against RSV disease in the broad infant population."
"We consider it a significant feat in the continued search for RSV prevention."
RSV is the most common cause of LRTIs and a leading cause of hospitalization in all infants, with most hospitalizations occurring in infants born healthy and at term.
RSV-related direct medical costs, including hospital, outpatient, and follow-up care, were estimated worldwide at €5 billion in 2019.
Beyfortus's development has been supported through EMA's PRIority MEdicines scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs. Additional designations have come from Japan, China, and the U.K.
The CHMP based its positive opinion on results from the Beyfortus clinical development program, including the Phase 3 MELODY, Phase 2/3 MEDLEY, and Phase 2b trials.
In the MELODY and Phase 2b trials, Beyfortus met its primary endpoint of reducing the incidence of medically attended LRTI caused by RSV during the RSV season vs. placebo with a single dose.
The safety profile of Beyfortus was similar to placebo. Beyfortus also demonstrated comparable safety and tolerability profile to Palivizumab in the Phase 2/3 MEDLEY trial.
And the U.S. CDC's vaccine committee meeting on June 23, 2022, reviewed a presentation: Nirsevimab For The Prevention of RSV Disease In All Infants.
What's next for Beyfortus?
After last week's CHMP endorsement, many people expect the European Commission to quickly issue its approval, which opens up access to this innovative RSV protection.
Furthermore, according to a previous Sanofi presentation delivered on July 30, 2020, the company believes they have produced a financial winner.
While Europe awaits this approval, several RSV vaccine candidates are fast approaching final endorsement by the U.S. FDA.
Other RSV vaccine candidate news is posted at PrecisionVaccinations.com/RSV.
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