Phase III Data in Hand, Sanofi-Regeneron’s Dupixent Targets Another Approval

Chesnot/Getty Images

Chesnot/Getty Images

Sanofi and Regeneron presented results from the Phase III PRIME trial that showed Dupixent strongly improves itching and skin lesions in adult patients with prurigo nodularis.

Courtesy of Chesnot/Getty Images

Sanofi and Regeneron Pharmaceuticals presented results Friday from the Phase III PRIME trial that showed Dupixent (dupilumab) strongly improves itching and skin lesions in adult patients with prurigo nodularis.

The data showed more than thrice as many Dupixent patients saw a clinically meaningful improvement in itching after 24 weeks of treatment compared to placebo (60% vs. 18%; p<0.0001). Disease activity, measured by a clinician using the Investigator’s Global Assessment scale, was also significantly better in the Dupixent arm, of whom nearly half achieved clear or nearly clear skin, as opposed to 18% in the placebo group (p=0.0004).

Enrolling more than 150 adult patients with uncontrolled prurigo nodularis, PRIME is a randomized and double-blinded study that compared Dupixent against placebo through 24 weeks of treatment. Before recruitment, participants who were already using low- or medium-dose topical corticosteroids or calcineurin inhibitors were allowed to continue their lotions or creams.

These findings were presented during a late-breaking session at the 2022 Congress of the European Academy of Dermatology and Venereology (EADV).

PRIME’s primary endpoint included changes in itch, as quantified by the Worst-Itch Numeric Rating Scale. Aside from efficacy, PRIME also looked at Dupixent’s safety in this patient population and found that while adverse events arose in 71% of Dupixent-treated patients, they were not significantly more common than in the placebo arm.

Dupixent’s toxicities in prurigo nodularis were also consistent with its safety profile in other immunological conditions for which the drug has already been approved.

In March, data from PRIME2, another Phase III prurigo nodularis trial, showed similar Dupixent performance, significantly reducing itch and leading to clear or very clear skin compared to placebo. PRIME2’s findings were presented at the Annual Meeting of the American Academy of Dermatology.

Together, data from PRIME and PRIME2 will form the foundation of approval filings for Dupixent for this indication to several regulatory bodies worldwide. The FDA and the European Commission are already reviewing submissions. Dupixent was granted a Fast Review designation by the FDA last May, and the federal agency is set to decide by Sept 30.

A Potent Agonist

Discovered through Regeneron’s proprietary VelocImmune platform and developed jointly with Sanofi, Dupixent is a human monoclonal antibody that seeks out interleukins 4 and 13 with high specificity, turning off these signaling cascades without exerting a systemic immunosuppressant effect.

Dupixent’s action of suppressing type 2 inflammation has earned it several regulatory approvals across different indications. The first of these came in March 2017, when the FDA greenlit the drug for moderate-to-severe atopic dermatitis in adults, making it the first-ever biologic approved for this indication.

Since then, Dupixent has collected regulatory nods for asthma, chronic rhinosinusitis with nasal polyps and eosinic esophagitis. Previous approvals had also been expanded to cover kids and teens.

Regeneron and Sanofi continue to study Dupixent, testing it in various immune-mediated diseases. At EADV, there will be 22 scientific abstracts on the drug, looking at its potential in chronic spontaneous urticaria, bullous pemphigoid and atopic dermatitis in infants. Dupixent is being investigated for other indications, including chronic pruritis of unknown origin, chronic obstructive pulmonary disease and allergic fungal rhinosinusitis.

Tristan is an independent science writer based in Metro Manila, with more than eight years of experience writing about medicine, biotech and science. He can be reached at, or on LinkedIn.