Sanofi’s Dupixent wins U.S. approval for bigger use

Sanofi on Friday won expanded U.S. approval for its best-selling Dupixent injection to treat an allergic inflammation of the esophagus, the Food and Drug Administration said.

There are more than 160,000 patients in the United States living with eosinophilic esophagitis, according to Sanofi.

The chronic condition typically requires repeated treatments such as corticosterioids and diet change to ease the symptoms and Dupixent is the first treatment that targets the underlying cause.

Anti-inflammation drug Dupixent, jointly developed with Regeneron, is already approved for a range of other uses including atopic dermatitis, also known as eczema, and severe asthma.

Sanofi said in March it expected peak annual sales of more than 13 billion euros ($13.77 billion) for the drug, up from a previous target of over 10 billion euros.

That excluded the potential use in COPD, sometimes called smoker’s lung, where trial results are expected next year.

Dupixent, with 2021 sales of 5.25 billion euros, accounted for 13.9% of group revenue, by far Sanofi’s best-selling product.

Sanofi’s first-quarter adjusted earnings gained 16.2% on sales growth of the blockbuster drug and a rebound in demand for prescription-free drugs.

First-quarter revenue from Dupixent jumped over 45% to 1.61 billion euros, beating an analyst consensus, on prescriptions in dermatitis, asthma and certain nasal infections.

(Reporting by Ludwig Burger; Additional reporting by Eva Mathews; Editing by Maju Samuel)