Sanofi, AstraZeneca win approval for RSV therapy manufacturing line

Sanofi and partner AstraZeneca 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.