EU Regulators Accept Dupilumab for Review

Regeneron and Sanofi’s highly-anticipated atopic dermatitis (AD) drug dupilumab, which they plan to market under the name Dupixent, has been accepted by the European Medicines Agency (EMA) for review.

The Marketing Authorization Application contains the results from a litany of trials, including SOLO 1 and 2, which showed the drug significantly outperforming placebo in patients with moderate-to-severe AD. Those two studies, which tested over 1,300 patients whose AD was rated 3 (moderate) or 4 (severe) on the Investigator’s Global Assessment (IGA; 0-4 scale) saw scores drop to 0 or 1 after 16 weeks in over 35% of all patients in both assessments, whether receiving the dug weekly or biweekly, compared to 10% or less in placebo groups. Three-fourths of those studied saw reductions on the Eczema Area and Severity Index, with minimal side effects reported.

The lead author of that report, Eric Simpson, spoke to MD Magazine in October, saying he was “quite surprised” at just how effective the drug was. “It was not clear which chemical messengers were most important in this condition…After many years of trying by many companies, Regeneron and Sanofi found two very important mediators of the disease.”

The drug targets the body’s interleukin (IL)-4 receptors to block signaling cytokines believed to play a major role in the manifestation of allergic diseases.

Dupixent is closer to approval on these shores than in Europe. The US Food and Drug Administration (FDA) accepted it for priority review earlier this year, and is expected to rule on March 29, 2017. The EMA’s review will still be underway at that point.

The drug may have application in other diseases, and phase 2 and 3 trials are currently underway to test its effectiveness against asthma.

Upon approval, both here and abroad, the drug is expected to be a massive financial success. Simpson, in our earlier interview, indicated why. “There will be cheaper options to treat atopic dermatitis systemically,” he said of dupilumab’s competition, “but they do not show the same level of effectiveness and are limited by significant side effects.”

Regeneron announced the news of the EMA’s application acceptance yesterday afternoon in a press release.

Related Coverage:

Dupilumab, A Promising Atopic Dermatitis and Asthma Drug, Fast-Tracked by FDA

New Trials Bolster Dupilumab's “First Line Treatment” Potential for Atopic Dermatitis

Drug Trial Shows Improved Quality of Life with Atopic Dermatitis Treatment