Sanofi and Regeneron’s Dupixent (dupilumab) has been recommended by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
If approved, Dupixent would be the first and only targeted medicine specifically indicated for prurigo nodularis in the EU.
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, underpinning the need for new treatment options.
Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.
The CHMP’s decision is based on positive results from two phase 3 trials, PRIME and PRIME2, in which Dupixent demonstrated a significant improvement in itch, skin lesions and health-related quality of life in adults with prurigo nodularis.
Both studies, involving 311 adults with uncontrolled prurigo nodularis that evaluated the efficacy and safety of Dupixent, met their shared primary endpoint of a clinically meaningful improvement in itch from baseline.
In the PRIME and PRIME2 studies, 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, respectively.
In the PRIME and PRIME2 studies, 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, respectively.
The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatology indication, the companies reported.
The European Commission is expected to announce a final decision on the Dupixent application in the coming months, the companies outlined in a statement.
Dupixent has already been granted approval by the US Food and Drug Administration (FDA) for the treatment of adult patients with prurigo nodularis.
In the September announcement, Naimish Patel, head of global development, immunology and inflammation at Sanofi, said the treatment 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.