The European Union’s drug regulator has recommended approval of AstraZeneca and Sanofi’s Beyfortus to prevent respiratory syncytial virus infection in newborns and babies, the companies said Friday. The antibody drug would be the first to be used broadly in those children.
Beyfortus is recommended as a preventive treatment for babies in their first RSV season, which like for colds and influenza runs from late autumn through spring. The drug is given as a single injection and, the companies report, reduced RSV infections requiring medical attention by 75% compared to a placebo in a Phase 3 trial.
The recommendation from the European Medicines Agency’s human drugs committee needs to be confirmed by the European Commission, which has two months to do so.
If authorized, Beyfortus will take on an antibody drug called Synagis, approved in 1998 and marketed in Europe by AstraZeneca and in the U.S. by the Stockholm-based drugmaker Swedish Orphan Biovitrum, or SOBI. Synagis is used in a smaller group: babies who are born prematurely and who are younger than 6 months old at the beginning of RSV season, and those with certain heart and lung conditions.
SOBI recorded U.S. Synagis sales of 2.7 billion Swedish krona ($318 million) in 2021, while AstraZeneca recorded $410 million in sales from the rest of the world.
As part of the 2018 transaction in which AstraZeneca sold U.S. rights, SOBI also acquired 50% of AstraZeneca’s earnings from Beyfortus. Under a 2017 collaboration with Sanofi, AstraZeneca is responsible for development and manufacturing, while Sanofi will handle commercialization.
Both antibody drugs could soon face competition from vaccines. While the first RSV vaccine trials to report positive data were in older adults, GSK is studying an RSV vaccine in 6-month-old babies while Pfizer and GSK are testing RSV vaccines in pregnant women to determine if it confers protection to babies after birth. GSK’s trial in pregnant women has been paused because of a safety concern, however.
Sanofi and AstraZeneca note Beyfortus provides long-acting protection against RSV infection without needing to activate the immune system.
RSV is a common infection that causes an estimated 360,000 hospitalizations and 24,000 deaths every year, but drugs and vaccines to prevent the disease as well as treatments have not been successful. Vaccines researched in the 1960s stimulated antibodies that weren’t protective and led to a type of immune response that can make the disease worse.
Recent research has resulted in an improved understanding of how to attack the virus, leading to a burst of new vaccine development.