The European Commission (EC) has granted expanded marketing authorisation for Sanofi’s Dupixent (dupilumab) for the treatment of moderate-to-severe prurigo nodularis in adults.
The treatment is indicated for usage in patients who are candidates for systemic therapy in the EU.
With the latest development, Dupixent became the first targeted therapy indicated for prurigo nodularis in Europe and the US.
The EC approval is based on findings from two Phase III clinical trials, PRIME and PRIME2.
The double-blind, placebo-controlled trials assessed the safety and efficacy of Dupixent versus placebo in adult uncontrolled prurigo nodularis patients.
At 12 weeks, clinically meaningful decline in itch was reported to be 44% and 37% in subjects who received Dupixent in the PRIME and PRIME2, respectively, versus 16% and 22% in placebo arms.
At 24 weeks, the improvement rose again, with nearly three times as many subjects in the Dupixent arm having a clinically meaningful decline in itch from baseline versus placebo.
In PRIME and PRIME2, 48% and 45% of subjects in the Dupixent arms had clear or almost clear skin at 24 weeks versus 18% and 16% for the placebo.
The safety data from the trials were generally in line with those reported for Dupixent in approved indications.
Sanofi Immunology and Inflammation Global Development head Naimish Patel said: “As the first and only targeted medicine approved to treat people living with prurigo nodularis, Dupixent has the potential to transform the standard-of-care for people in Europe living with this debilitating skin disease.
“In the pivotal trials, patients treated with Dupixent experienced significant improvements in key hallmarks of the disease, such as reduction in itch and achieving clearer skin, as well as broader impacts on their daily lives.”
In August, the US Food and Drug Administration (FDA) accepted the company’s Biologics License Application for efanesoctocog alfa (BIVV001) to treat haemophilia A for priority review.