Sanofi has received the green light from the Committee for Medicinal Products for Human Use (CHMP) for the drug nirsevimab to prevent bronchiolitis in infants, it announced on Friday.
Nirsevimab, jointly developed by Britain’s AstraZeneca and France’s Sanofi, which will market it as Beyfortus, is an antibody designed to protect children throughout the season against respiratory syncytial virus (RSV), the virus that causes bronchiolitis.
The CHMP gave a positive opinion and recommended approval of Beyfortus for the prevention of lower respiratory tract infections caused by RSV in infants and young children during the first circulating season of the virus in which they are exposed.
If later approved by the European Commission, Beyfortus will become the first and only passive immunization intended for all newborns, including those who are healthy, born prematurely or prematurely, or those with certain health conditions. notes Sanofi in its. in a press release.
Cough and difficulty breathing
Bronchiolitis is a common and highly contagious respiratory disease, especially in infants aged 2 to 8 months, where it causes coughing and labored breathing. Each year in France, up to 30% of infants under the age of two are affected.
Most of the time, the disease is mild. But it may require a visit to the emergency room or even hospitalization.
“It is the first cause of hospitalization in children under one year of age,” emphasizes Jean-Francois Toussaint, head of Sanofi’s vaccine research and development department.
Beyfortus differs from vaccines with traditional technologies, because it is a monoclonal antibody, that is, an antibody developed in the laboratory, which enables a single dose to give the infant so-called passive immunity.
The child has not yet been able to build his own immune response, “we give him antibodies that will protect him,” Jean-Francois Toussaint explained to AFP.
To date, there is only one vaccine (again, a preventive drug) against bronchiolitis, sold by AstraZeneca under the name Synagis.
But this drug has marketing approval only for at-risk or premature babies and requires multiple doses.
The Committee for Medicinal Products for Human Use is the body responsible for examining medicines marketed in the European Union. The European Commission, which is responsible for approving medicines, usually makes its recommendations within two months.
In this positive view, Sanofi and AstraZeneca therefore lead the laboratories developing bronchiolitis vaccines, which represent a huge potential market. Others are also in the running, including Moderna, for example, which is developing a messenger RNA vaccine against RSV, but this time for the elderly.
Source: Le Figaro
