Sometime over the next few days or weeks, the FDA will likely hand Regeneron and Sanofi an approval for Dupixent (dupilumab), their groundbreaking IL-4/IL-13 inhibitor for eczema which a number of analysts have projected will go on to grab $4 billion-plus a year in annual sales. And they’ll hit the market with some stellar new 16- and 52-week data from another Phase III study as they go up against Pfizer’s newly approved Eucrisa (crisaborole, targeting PDE4).
We knew last year that dupilumab had hit its marks in the pivotal SOLO trials as well as CHRONOS, setting it up as possibly the top drug launch slated for 2017. Over the weekend, investigators turned out with some new goal post data for CHRONOS that will do nothing to take the shine off of its big market predictions.
In CHRONOS, researchers recruited patients whose eczema wasn’t controlled by topical therapies including corticosteroids. They were divvied up into three groups: weekly 300 mg doses of dupilumab with topical corticosteroids (TCS), once every two weeks doses with TCS or TCS alone.
In the new CHRONOS data reviewed at the annual meeting of the American Academy of Dermatology in Orlando over the weekend, investigators noted that the severe itching patients are afflicted by was reduced by 55% and 58% in the two drug arms after 16 weeks, compared to 29% of patients on TCS alone. And the disease score rating for patients dropped by 4 or more points among 77% of the patients in the drug arms compared to 37% of the placebo/topical corticosteroid group.
At 52 weeks the improvement in the itching score held steady at 54% and 56% in the drug ams and 27% in the placebo group. And the 4-point-plus improvement in disease score was maintained by 65% and 76% of the patients on drug, compared to 26% on only topical corticosteroids.
Compare that to the primary goal in the crisaborole study for mild to moderate eczema:
More crisaborole- than vehicle-treated patients achieved (Investigator’s Static Global Assessment) score success (clear/almost clear with ≥2-grade improvement; AD-301: 32.8% vs 25.4%, P = .038; AD-302: 31.4% vs 18.0%, P < .001), with a greater percentage with clear/almost clear (51.7% vs 40.6%, P = .005; 48.5% vs 29.7%, P < .001).
That’s what Pfizer paid $5.2 billion for when it acquired Anacor.
Together, these drugs are expected to make a crucial difference for a big group of patients who have limited treatment options. But Regeneron and Sanofi are clearly gunning for the lion’s share of the market with a much broader range of late-stage data to take to payers and physicians.
They need a clear win here. Their drug sarilumab was held up by the FDA last fall over manufacturing issues. And their big PCSK9 play turned into an embarrassing defensive effort to beat back a judge’s ruling that their drug should be pulled due to patent violations.
“These new results build upon previous positive Phase III monotherapy data. In the CHRONOS study, Dupixent used with topical corticosteroids showed significantly greater clearance of skin lesions and overall disease severity compared to topical corticosteroids alone, which are commonly prescribed for moderate-to-severe atopic dermatitis,” said Andrew Blauvelt, president of Oregon Medical Research Center and principal investigator of the study. “This study provides positive long-term data for Dupixent, which is important given atopic dermatitis is a chronic inflammatory disease. Additionally, the presentation highlights the critical role of IL-4 and IL-13 as drivers of this atopic condition.”
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