Green light for Sanofi. The pharmaceutical laboratory has obtained the agreement of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the future marketing of nirsevimab, a drug intended to prevent bronchiolitis in newborns, he announced on Friday. Developed jointly by the British AstraZeneca and the French Sanofi, which will market it under the name Beyfortus, nirsevimab is an antibody designed to protect infants throughout the respiratory syncytial virus (RSV) circulation season, virus causing bronchiolitis.
The CHMP issued a favorable opinion and recommended the approval of Beyfortus for the prevention of lower respiratory tract infections caused by RSV in newborns and infants, during the first season of circulation of the virus that they face. If subsequently approved by the European Commission, Beyfortus will become the first and only single-dose passive immunizing agent indicated for all infants, including those who are healthy, born at term or prematurely, or those with certain conditions of health, specifies Sanofi in its press release.
Bronchiolitis is a common and highly contagious respiratory disease, especially in infants 2 to 8 months old, where it causes coughing and labored breathing. Every year in France, 30% of infants under the age of two are affected.
Leading cause of hospitalization in children under one year old
Most of the time, the disease is mild. But it may require a trip to the emergency room, or even hospitalization. “This is the leading cause of hospitalization in children under one year old,” said Jean-François Toussaint, head of R&D in vaccines for Sanofi.
Beyfortus differs from vaccines using traditional technologies because it is a monoclonal antibody, that is to say an antibody developed in the laboratory, which makes it possible to confer so-called passive immunity on the infant, with a single dose. The infant has not yet been able to build his immune response, “we give him antibodies that will protect him,” explains Jean-François Toussaint.
To date, there is only one vaccine (again a preventive medicine) against bronchiolitis, marketed by AstraZeneca under the name Synagis. But this drug has a marketing authorization only in at-risk or premature children, and requires several doses.
Huge potential market
The Committee for Medicinal Products for Human Use is the body responsible for examining medicinal products which may be marketed in the European Union. The European Commission, which is in charge of approving drugs, generally aligns itself with its recommendations within two months.
With this positive opinion, Sanofi and AstraZeneca are therefore at the head of the laboratories developing vaccines against bronchiolitis, which represents a huge potential market. Others are also in the running, including for example Moderna, which is developing a messenger RNA vaccine against RSV, but this time for the elderly.