Sept 16 (Reuters) -
Sanofi and partner AstraZeneca ( AZN ) have
received approval from the U.S. Food and Drug Administration for
a manufacturing line for their preventive respiratory syncytial
virus (RSV) therapy, the French drugmaker said on Monday.
The expanded capacity will help the drugmakers meet the
demand for Beyfortus ahead of the RSV season. The therapy was in
tight supply last year.
The U.S. health regulator greenlit the injected antibody
therapy in July last year to prevent RSV in infants and
toddlers.
The company said injection doses of the therapy are
ready to be shipped, which will improve supply for the Northern
Hemisphere ahead of the 2024-2025 RSV season.
Sanofi did not immediately respond to a Reuters request
for comment on when the filling line was approved.
The company said it is shipping 50mg and 100mg doses of
Beyfortus to the United States to help ensure a majority of the
doses are available.
RSV is a common respiratory virus that infects the nose,
throat, and lungs.
It is a leading cause of hospitalization among infants,
affecting two out of three infants during their first year of
life.