Even as its diabetes unit struggles, Sanofi has made strides on the market with Dupixent since launching last year in eczema. Now, with an FDA approval (PDF) late Friday in asthma, one analyst believes the drug is set for a $2.5 billion sales boost thanks to strong efficacy and safety, along with a broad label.
The FDA signed off on Sanofi and Regeneron’s Dupixent as an add-on maintenance treatment for asthma patients 12 and older with an eosinophilic phenotype or for those who are dependent on oral corticosteroids. As Leerink analyst Geoffrey Porges put it in a note following the approval, the company appears to have “achieved the Goldilocks of labels compared to rivals.”
Dupixent is now the only asthma biologic that patients can administer at home, as well as the only biologic to treat moderate and severe patients with an eosinophilic phenotype or those who are dependent on an oral corticosteroid.
Those are some of the factors that led Porges to project $2.5 billion in peak asthma sales for the drug. Leerink’s estimate for peak Dupixent sales overall is $7.5 billion, compared with consensus estimates of $5.4 billion.
“We believe the label’s superior efficacy, dosing convenience, lack of Black Box warnings, and market expansion opportunities support our Dupixent forecast,” Porges wrote. Dupixent should ultimately lead in market share against already approved competitors Cinqair from Teva, Xolair from Roche and Novartis, Nucala from GlaxoSmithKline and Fasenra from AstraZeneca, the analyst wrote.
Dupixent won its initial approval last year in atopic dermatitis, and the drug has quickly gained steam in the indication after its launch. In the first half of 2018, sales rang in at €283 million. Looking ahead, Sanofi and Regeneron are looking to expand into new uses and last week posted positive data from two phase 3 trials of Dupixent in patients with rhinosinusitis and nasal polyps.
Dupixent's asthma approval comes as Sanofi’s crucial diabetes unit continues to struggle thanks to pricing and competitive pressures. In the first half of the year, diabetes sales came in at €2.7 billion, an 11% decline from last year.