FDA Calendar

Company Name Sanofi
Drug Name Dupixent (sBLA)
Event Name FDA decision on Dupixent in the expanded use of treating adult and pediatric patients aged 12 years and older with eosinophilic esophagitis
Event Date 08/03/2022
Outcome Date 05/20/2022
Outcome FDA approved Dupixent as first treatment for adults and children aged 12 and older with eosinophilic esophagitis on May 20, 2022
Drug Status Dupixent is being jointly developed by Regeneron and Sanofi
Rival Drugs Currently, there are no FDA-approved treatments for eosinophilic esophagitis
Market Potential In full year 2021, Dupixent sales were €5,249 million, up 52.7%, of which €3,971 million were generated in the U.S. (up 46.2%).
Other Approvals Dupixent is already approved in the U.S. for patients aged 6 years and older with uncontrolled moderate-to-severe atopic dermatitis; as an add-on maintenance treatment of patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma; and for use with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled.
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