Sanofi's Dupixent wins U.S. approval for bigger use
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[May 20, 2022]
(Reuters) -Sanofi 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 on Friday.
There are more than 160,000 patients in the United States living with
eosinophilic esophagitis (EoE), according to Sanofi.
Sanofi's regulatory filing for EoE is under review by the European
Medicines Agency, the company said, adding that submissions to
regulatory authorities in additional countries are planned by the end of
2022.
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.
Shares of Regeneron reversed course to close up 1% on Friday.
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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 chronic obstructive pulmonary
disease (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.
Revenue from Dupixent jumped over 45% to 1.61 billion euros in the
quarter, 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)
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