The approval of the fully human monoclonal antibody in the new indication in the European Union was based on the findings of the PRIME and PRIME2 phase 3 trials
EC has approved Sanofi’s Dupixent in the EU for the treatment of prurigo nodularis in adults. (Credit: Avi1111 dr. avishai teacher/Wikimedia Commons)
Sanofi has secured expanded marketing authorisation for its allergic diseases drug Dupixent (dupilumab) from the European Commission (EC) to include its use in the treatment of moderate-to-severe prurigo nodularis in adults.
The fully human monoclonal antibody is indicated for usage in patients who are eligible for systemic therapy.
The approval makes Dupixent the first and only targeted medicine indicated specifically to treat prurigo nodularis in Europe and the US, said Sanofi. It has been based on the findings of the PRIME and PRIME2 phase 3 trials.
Both the double-blind, placebo-controlled trials assessed the efficacy and safety of Dupixent in adults having uncontrolled prurigo nodularis compared to the placebo.
According to Sanofi, 44% and 37% of subjects in the Dupixent arm in the PRIME and PRIME2 trials, respectively, reported a clinically meaningful decline in itch at the end of 12 weeks, versus 16% and 22%, respectively in the placebo arms.
In the PRIME and PRIME2 trials, 48% and 45%, respectively, of subjects in the Dupixent arm had clear or almost clear skin at 24 weeks, versus 18% and 16%, respectively, for the placebo.
At the end of 24 weeks, Dupixent also considerably enhanced health-related quality of life, while lowering measures of skin pain and symptoms of anxiety/depression from baseline.
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.”
The French pharmaceutical firm added that the safety data from the two trials were consistent with the known safety profile of Dupixent in its approved indications.