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Sanofi, AstraZeneca win US approval for RSV therapy manufacturing line
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Sanofi, AstraZeneca win US approval for RSV therapy manufacturing line
Sep 16, 2024 12:01 PM

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.

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