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Sanofi: requests additional license for Dupixent

(CercleFinance.com) - Sanofi has announced that the US Food and Drug Administration (FDA) has agreed to consider the application for an additional biologic product license (sBLA) for its human monoclonal antibody Dupixent (dupilumab).

This application is for authorisation as a supplementary maintenance treatment in moderate-to-severe asthma in certain categories of adults and teenagers (12 years and older). The FDA will give its decision on 20 October 2018.

The French health giant adds that demand is based on the clinical data of 2,888 adults and teenagers who took part in the three pivotal trials of the Liberty Asthma clinical development program.

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