Sanofi has won wide-ranging U.S. approval for its best-selling duplex injection for the treatment of allergic inflammation in the esophagus, the Food and Drug Administration said Friday.
According to Sanofi, more than 160,000 patients in the United States live with eosinophilic esophagitis (EOE).
Sanofi’s regulatory filing for the EoE is under review by the European Medicines Agency, which says it plans to submit it to regulatory authorities in additional countries by the end of 2022.
Chronic conditions usually require frequent treatment such as corticosteroids and dietary modification to ease the symptoms and dupixant is the first treatment that addresses the underlying cause.
The anti-inflammatory drug Dupixant, co-developed with Regeneron, is already approved for other uses, including atopic dermatitis, eczema, and severe asthma.
Shares of Regeneron tumbled as much as 1% on Friday.
Sanofi said in March that it expects a maximum annual drug sales of 13 billion euros ($ 13.77 billion) from the previous target of 10 billion euros.
This excludes the potential use of Chronic Obstructive Pulmonary Disease (COPD), sometimes referred to as smokers’ lungs, where test results are expected next year.
Dupixant, with sales of 5.25 billion euros in 2021, accounted for 13.9% of the group’s revenue, Sanofi’s best-selling product to date.
Sanofi’s first-quarter consistent revenue grew 16.2% as sales of blockbuster drugs increased and demand for prescription-free drugs increased.
Dupixent’s revenue from prescriptions for dermatitis, asthma and some nasal infections rose more than 45% to 1.61 billion euros in the quarter, missing an analyst’s consensus. (Reporting by Ludwig Burger; Additional reporting by Eva Matthews; Editing by Maju Samuel)