Regeneron exec says it's 'just the beginning' for Dupixent in type 2 inflammation, as the Sanofi-partnered blockbuster clinches another win ahead of FDA verdict in prurigo nodularis

As Sanofi and Regeneron Pharmaceuticals’ immunology superstar Dupixent continues its ascent, racking up back-to-back approvals this year in conditions like eosinophilic esophagitis and pediatric eczema, the IL-4/IL-13 inhibitor has charted a late-stage win showing it can tackle yet another form of type 2 inflammation, this time afflicting the skin.

Dupixent, also known as dupilumab, “significantly” curbed itch and skin lesions after 24 weeks in prurigo nodularis, according to data from the late-stage Prime trial presented by the partners at the European Academy of Dermatology and Venereology’s 2022 annual congress.

Sanofi and Regeneron’s antibody aced both primary and key secondary endpoints in the phase 3 study, which is the second of two late-stage trials that form the basis of the partners’ FDA approval submission.

Dupixent is up for priority review in prurigo nodularis, with the FDA scheduled to hand down its decision by Sept. 30.

If approved for the chronic skin condition, Dupixent would become the first drug specifically approved for prurigo nodularis. The current standard of treatment is topical steroids, which can have severe side effects if used over a long stretch of time.

It’s estimated that there are about 145,000 adults with prurigo nodularis in the U.S. and Europe, and “many more” people worldwide struggle to control their disease with topical therapies, a Sanofi spokesperson said via email.

While prurigo nodularis may not have the same notoriety as atopic dermatitis—or eczema—“in terms of dermatological conditions, it actually has one of the greatest impacts on patients’ quality of life,” Bola Akinlade, M.D., SVP and therapeutic area head of immunology and inflammation at Regeneron, said in an interview.

The disease is often misunderstood, too, added Naimish Patel, M.D., Sanofi’s SVP and global development head for immunology and inflammation.

Because patients have long suffered with subpar steroid treatments, people with prurigo nodularis often contend with “unrelenting itch all the time,” Patel said, which physicians sometimes assume is just in the patient’s head.

The Prime data “obviously turns that all completely upside down,” Patel added.

As with many diseases where treatment options are sparse, diagnoses are likely underreported, Patel and Akinlade figure. Should Dupixent hit the scene in prurigo nodularis, Sanofi and Regeneron expect to see diangosis stats go up.

“You’ll probably find out that a lot more patients may actually be diagnosed with prurigo nodularis,” Akinlade said.

At the Prime trial’s 24-week mark, 60% of Dupixent patients—more than three times as many as those on placebo—saw clinically meaningful reductions in itch from baseline, which was the study’s primary marker of success.

Meanwhile, 48% of patients on Sanofi and Regeneron’s drug achieved clear or almost-clear skin versus patients in the control cohort.

Safety was generally on par with Dupixent’s known profile in its other dermatology indications, Sanofi and Regeneron said in a release.

Back in October 2021, meanwhile, Sanofi and Regeneron issued their first clutch of late-stage prurigo nodularis data from Dupixent’s Prime2 study. In addition to similar itch and skin clearance data as the Prime results, Prime2 also found the antibody charted greater improvements than placebo in addressing anxiety and depression symptoms.

Aside from prurigo nodularis, Sanofi and Regeneron are testing Dupixent in a trio of other skin conditions with underlying type 2 inflammation. Those are atopic dermatitis in patients as young as six months old—where Dupixent is approved in the U.S. and awaiting a decision in that age group from the EMA—plus chronic spontaneous urticaria and bullous pemphigoid.

Regeneron’s Akinlade figures it’s “just the beginning” of Dupixent’s continued growth in a range of conditions underpinned by type 2 inflammation. Patel concurred, noting that Dupixent’s journey is still “mid-stream.”

“Clearly, Dupixent remains the No. 1 driver of our growth story,” Sanofi’s chief executive Paul Hudson said on the company’s recent second-quarter earnings call. For the second three months of 2022, Dupixent pulled down sales of 1.96 billion euros, growing 43.4% at constant currencies, Sanofi said at the time.

The idea that Dupixent is just at the start of its ascent is a common refrain for Sanofi, which recently upgraded its peak sales target for the med from 10 billion euros to more than 13 billion euros (about $14.44 billion). Upcoming readouts in chronic obstructive pulmonary disease due next year could drive that sales potential even higher.

Dupixent was originally approved in the U.S. in 2017 for eczema. Since then, it's won green lights in three diseases across multiple age groups. This year alone, Dupixent racked up wins in atopic dermatitis, severe asthma including in younger patients and an approval as the first medication to treat eosinophilic esophagitis.