Sanofi/Regeneron's Duxipent Scores First US Approval for Prurigo Nodularis

FDA_Sarah Silbiger/Getty Images

Courtesy of Sarah Silbiger/Getty Images

The FDA has given Regeneron and Sanofi’s Dupixent (dupilumab) its regulatory go-ahead for the treatment of adult patients with prurigo nodularis, marking the first drug approved for this indication.

Data from two Phase III trials, PRIME and PRIME2, formed the basis for the FDA’s green light. Nearly three times as many Dupixent-treated patients reached PRIME’s primary endpoint, which was a clinically meaningful improvement in itch from baseline to 24 weeks, as compared with placebo.

Dupixent also cleared PRIME2’s primary endpoint, inducing a similar improvement in itch in treated patients at 12 weeks, relative to placebo comparators.

After 24 weeks of treatment, patients receiving Dupixent also achieved clear or almost clear skin at more than twice the rate of their placebo counterparts. Even when combining both metrics - itch and clear skin - Dupixent was able to demonstrate clinically meaningful improvements in three times as many patients as placebo.

“Prior to Dupixent’s approval, there were no FDA-approved medicines indicated for the treatment of prurigo nodularis,” a Dupixent spokesperson told BioSpace. “High-potency topical steroids are commonly prescribed off-label but these can be associated with safety risks if used long-term.” 

Dupixent’s safety profile in PRIME and PRIME2 was also generally consistent with what had been established in the drug’s approved dermatology indications. The most common side effects were nasopharyngitis, conjunctivitis, herpes infection, dizziness, muscle pain and diarrhea.

The European Medicines Agency is also reviewing a regulatory filing for Dupixent in prurigo nodularis. The companies will make submissions to other countries within the year.

A Blockbuster IL-4/13 Blocker

Discovered and developed primarily through Regeneron’s proprietary VelocImmune technology, Dupixent is a fully human monoclonal antibody approved for various allergic and inflammatory diseases, such as asthma, eczema, atopic dermatitis, chronic rhinosinusitis with nasal polyposis and eosinic esophagitis.

The drug, administered through a subcutaneous injection, works by targeting and blocking both interleukin-4 and interleukin-13, in turn deactivating their downstream pathways. Through this mode of action, Dupixent has shown strong suppressive action against type 2 inflammation in Phase III trials. The drug is not an immunosuppressant.

Dupixent has consistently been among Sanofi’s strongest assets. In the second quarter of this year, the company’s Specialty Care program earned nearly $4 billion, almost half of which could be attributed to Dupixent sales. Compared to the same period a year prior, Dupixent’s Q2 income represented a more than 43% growth.

Regeneron is also reaping Dupixent’s benefits. The company named Sanofi its most profitable collaborator in Q2, earning nearly $680 million from this partnership, up 55% from the same period the year before.

The companies continue to investigate Dupixent in other allergic or inflammatory indications, the spokesperson said. Phase III studies are ongoing for hand and foot atopic dermatitis, chronic spontaneous urticaria, chronic pruritus of unknown origin and chronic obstructive pulmonary disease with evidence of type 2 inflammation.

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