Sanofi and Regeneron’s Dupixent approved by FDA for prurigo nodularis

Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with prurigo nodularis, making it the first and only medicine for this specific indication in the US.

Affecting approximately 75,000 of adults in the US alone, prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and its impact on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch it causes.

High-potency topical steroids commonly prescribed for the treatment of the disease are associated with safety risks if used long term, highlighting the need for new treatment options.

Naimish Patel, head of global development, immunology and inflammation at Sanofi, said: "Until today, there were limited treatment options to manage the relentless itch and associated sensations of burning and stinging skin that can negatively impact the lives of patients struggling with prurigo nodularis.

"Dupixent has the potential to transform the standard-of-care for prurigo nodularis patients by alleviating the key hallmarks of the disease, such as reducing itch and achieving clearer skin.”

The FDA’s decision is based on positive results from PRIME and PRIME2, the two phase 3 trials involving 311 adults with uncontrolled prurigo nodularis that evaluated the efficacy and safety of Dupixent.

Both studies met their shared primary endpoint of a clinically meaningful improvement in itch from baseline. In the PRIME study, 60% and 58% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline after 24 weeks, compared to 18% and 20% for placebo.

In the PRIME2 study, 44% and 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline after 12 weeks, compared to 16% and 22% for placebo.

The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatology indication, the companies reported.

"Dupixent has already transformed the treatment landscape of several diseases driven by type 2 inflammation… With this approval, those suffering with prurigo nodularis finally have a medicine to address the debilitating signs and symptoms of the disease,” said George Yancopoulos, president and chief scientific officer at Regeneron, and a principal inventor of Dupixent.

A regulatory filing for prurigo nodularis is under review by the European Medicines Agency and submissions to regulatory authorities in additional countries are also planned in 2022, the companies outlined.