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Sanofi, Regeneron Win FDA Approval for Eczema Drug With Multi-Billion Dollar Potential

Allergy Test, ChildAllergy Test, Child
A child with eczema.Photograph by BSIP UIG via Getty Images

French drug giant Sanofi and partner Regeneron (REGN) scored a critical victory Tuesday as the Food and Drug Administration (FDA) approved their new drug, dupilumab (brand name Dupixent) to treat the skin rash atopic dermatitis, aka eczema. Analysts have said that the drug could become a blockbuster therapy that could one day bring in more than $3 billion in annual sales.

Eczema is an extremely common skin condition, often treated with topical ointments. But Dupixent is an injectable drug meant for patients with more persistent forms of the inflammatory disease that don’t respond to those methods. As such, it also comes with a pretty hefty price tag – to the tune of a $37,000 yearly list price.

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That high price could be part of the reason why the approval didn’t translate into notable stock gains in Tuesday trading. There’s also the matter of Sanofi/Regeneron’s potential patent spat with rival Amgen (AMGN) over certain molecules used in the treatment. Amgen won a separate patent case against the two firms centered on a cholesterol-slashing drug earlier this year.

Still, Dupixent’s imminent arrival to the U.S. market is welcome news for Sanofi. The diabetes specialist has seen sales stall in its flagship unit and failed to close a hotly-sought deal for European biotech Actelion, losing out to Johnson & Johnson (JNJ).