FDA puts 'priority' stamp on Sanofi and Regeneron's next blockbuster hopeful


Sanofi and Regeneron’s next wannabe blockbuster is officially in regulators’ hands--but with the candidate tapped for a speedy review process, it may not stay there for long.

On Monday, the drugmakers announced that the FDA had accepted their application for atopic dermatitis candidate dupilumab and given it a priority review tag that should hasten its trip to approval. The agency will now have until March 29 to hand down a decision on the prospect, they said.

Unlike Sanofi and Regeneron’s first effort--PCSK9 med Praluent, which competes with Amgen’s Repatha--dupilumab will be the only med in its class on the market if it does win a go-ahead. Current options for eczema patients include immunosuppressants such as cyclosporine--which can increase the risk of dangerous infections and cancer--and topical steroids, whose own set of potential side effects includes skin-thinning.

Dupilumab has already shown it can beat out those topical steroids, too. In June, its makers rolled out Phase III data showing that a dupilumab/corticosteroid combo topped steroids alone. Four out of 10 patients on the newcomer demonstrated a complete or near-complete clearing of skin lesions, with 64% achieving a 75% elimination of eczema.

With that in mind, analysts see dupilumab generating more than $2.5 billion a year--with some predicting up to $4 billion or $5 billion.

But despite the lofty forecasts, the pair isn’t letting up. It already has dupilumab in Phase III asthma trials, and it’s testing the drug in chronic sinusitis and eosinophilic esophagitis, too.

- read the release

Related Articles:
With dupilumab data, Sanofi, Regeneron gear up for potential $5B in sales
Amgen, Sanofi and Regeneron trot out new PCSK9 data at European heart meeting
Regeneron, Sanofi take another big step toward quick dupilumab OK
Regeneron speeds toward the FDA with its would-be asthma blockbuster