Sanofi and AstraZeneca Secure FDA Approval for RSV Therapy Manufacturing Line

Sanofi, in partnership with AstraZeneca, has received approval from the U.S. Food and Drug Administration (FDA) for a new manufacturing line dedicated to producing their preventive respiratory syncytial virus (RSV) therapy, Beyfortus. The French pharmaceutical company announced this development on Monday, marking a significant step forward in meeting the rising demand for RSV prevention as the upcoming RSV season approaches.

The expansion in manufacturing capacity comes as a relief after last year’s supply shortage, ensuring that more doses of Beyfortus will be available for infants and toddlers who are at risk of contracting RSV. The therapy, which received FDA approval in July of last year, is specifically designed to prevent RSV infections in young children—a virus that is known to cause severe respiratory infections and is a leading cause of hospitalizations among infants.

Sanofi has confirmed that doses of the injectable therapy are ready for shipment, ensuring improved supply for the Northern Hemisphere in advance of the 2024-2025 RSV season. The company is shipping both 50mg and 100mg doses to the United States to help meet demand and ensure that a majority of patients can access the treatment.

While Sanofi did not provide immediate details on when the new manufacturing line was approved, this expansion is expected to alleviate previous supply constraints, making Beyfortus more widely available.

RSV is a common respiratory virus that affects the nose, throat, and lungs, and most children are infected within their first year of life. With the expanded production of Beyfortus, Sanofi and AstraZeneca are taking a proactive approach to addressing this serious health concern.

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