FDA approves Beyfortus (nirsevimab-alip) to
protect infants against RSV disease.
Paris: On 17th July 2023,
The U.S. Food and Drug Administration (FDA) has approved Sanofi and
AstraZeneca’s Beyfortus (nirsevimab-alip), which is a first monoclonal antibody
approved for the prevention of respiratory syncytial virus (RSV) lower
respiratory tract disease (LRTD) in all infants during their first RSV season.
Also, the approval includes the use for children up to 24 months of age who
remain vulnerable to severe RSV disease in their second RSV season.
RSV is a common respiratory
virus that can cause severe respiratory illness, especially in infants and
young children. According to the Centers for Disease Control and Prevention,
RSV is the most common cause of bronchiolitis and pneumonia in children under
one year of age in the United States. There is currently no approved vaccine
for RSV.
Beyfortus is a monoclonal
antibody that targets the RSV fusion protein, which is essential for the virus
to infect cells. By binding to the fusion protein, Beyfortus prevents the virus
from entering cells and causing infection. The FDA approval of Beyfortus was
based on data from a Phase 3 trial that enrolled approximately 1,500 healthy
preterm infants and term infants who were born during the RSV season or within
six months prior to the start of the season. The primary endpoint was met,
reducing the incidence of medically attended RSV LRTD by 74.9% compared to
placebo. The efficacy of Beyfortus against the secondary endpoint of
hospitalization was 60.2%. The safety data for Beyfortus was consistent with
that observed in previous studies, and no new safety signals were identified in
the Phase 3 trial.
In addition, Beyfortus is
administered as a single injection once a month during the RSV season, which
typically lasts from November to April in the United States. The approval of
Beyfortus provides a new option for the prevention of RSV LRTD in infants and
young children who are at high risk for severe RSV disease. In October 2022,
the European Union approved Beyfortus, which was developed in collaboration by
Sanofi and AstraZeneca. Subsequently, in November 2022, it received approval in
Great Britain, and in April 2023, it was also approved in Canada. At present,
regulatory applications for Beyfortus are being reviewed in China, Japan, and
several other countries.
According to the Executive
Vice President of Sanofi,
“Today’s approval marks an unprecedented moment for protecting infant health in
the U.S., following an RSV season that took a record toll on infants, their
families, and the U.S. healthcare system. Beyfortus is the only monoclonal
antibody approved for passive immunization to provide safe and effective
protection for all infants during their first RSV season. I am proud that, by
prioritizing this potential game-changer, we are now about to bring Beyfortus
to American families.” Further, the Executive Vice President, AstraZeneca, commented:
“Beyfortus represents an opportunity for a paradigm-shift in preventing
serious respiratory disease due to RSV across a broad infant population in the
U.S. The science that Beyfortus is built on demonstrates AstraZeneca’s
continued leadership in addressing the needs of the most vulnerable populations
and reducing the burden on healthcare systems.”
According to TechSci Research, the FDA approval of
Beyfortus (nirsevimab-alip) is a significant milestone for both the monoclonal
antibody market and respiratory diseases. The approval of Beyfortus represents
a new treatment option for respiratory diseases, specifically for the
prevention of respiratory syncytial virus (RSV) lower respiratory tract disease
(LRTD) in newborns and infants. This approval opens up a new market segment for
monoclonal antibodies and demonstrates the potential for this class of drugs to
address unmet medical needs in the field of respiratory diseases. Also, the
approval has increased awareness of monoclonal antibodies and their potential
to treat respiratory diseases, which in turn is expected to generate a significant
interest from the pharmaceutical industry and investors, driving innovation and
growth in monoclonal antibodies market. Furthermore, the approval of Beyfortus
for the prevention of RSV LRTD in newborns and infants may lead to the
development of additional monoclonal antibodies for the prevention and
treatment of other respiratory infections and diseases. This could further
drive growth in the monoclonal antibody market and respiratory diseases.