Sanofi and Regeneron, whose Dupixent is slated to reach peak sales of at least $4 billion, have continued pumping out new data ion the hope of getting it there sooner rather than later.
And today’s results comes at an important time, since contenders from other drugmakers also are starting to announce promising results in areas where the two hope Dupixent will dominate.
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Today Sanofi and Regeneron reported out results from the phase 3 CAFE study of Dupixent in treating atopic dermatitis in combo with topical corticosteroids (TCS) and compared to patients whose eczema is being treated with cyclosporine A (CSA). But since use of CSA is not an approved treatment in the U.S., the data applies more to Europe and Japan, where it is.
They said the drug, which in July was recommended for approval in Europe for treating acute dermatitis, met its primary endpoint of at least a 75% score in a test that measures improvement in the affected area. The data showed 59% patients who took Dupixent in combo with topical corticosteroids weekly reached that improvement threshold, while 63% who took it every two weeks did. That compared to 30% taking the TSA treatment.
"In the CAFÉ study, Dupixent with topical corticosteroids significantly improved overall measures of disease severity including lesions, itch, quality of life measures and symptoms of anxiety and depression in these patients," Dr. Marjolein De Bruin-Weller, a dermatologist at the National Expertise Center for Atopic Dermatitis at the University Medical Center Utrecht, said in the statement released by the two drugmakers.
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Earlier this month, AbbVie released phase 2b data showing its JAK-1 selective inhibitor upadacitinib hit its primary endpoints in atopic dermatitis. While analysts said Dupixent should maintain its market-leading position, they said, if approved, it could steal some of that market share.
The big advantages of the AbbVie candidate, and other JAK inhibitors also under development, is that they can be taken by mouth instead of the every-two-week injections required by Dupixent.
Sanofi and Regeneron also expect the drug to be approved for treating other conditions, and just last week reported it reduced the frequency of severe asthma attacks by 46% in the overall and by 60% to 67% in patients with high levels of eosinophilic cells.
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But here again, Dupixent is up against some potentially strong competition. GlaxoSmithKline’s Nucula already leads in that market and AstraZeneca and Amgen last week reported out phase 2 data for severe asthma for their first-in-class thymic stromal lymphopoietin antagonist, tezepelumab.
The AstraZeneca drug is expected by analysts to be a significant player in a what looks to become a competitive market and noted it might get FDA approval on the strength of the phase 2b data while they carry out a confirmatory phase 3 trial. The FDA did that with Dupixent.
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