Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the European Commission (EC) for the treatment of adult patients with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
The decision, which follows a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use, makes Dupixent 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, as reported by the companies, 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, underscoring 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.
“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,” Naimish Patel, head of global development, immunology and inflammation at Sanofi.
The EC’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-treated patients experienced a clinically meaningful reduction in itch from baseline after 12 weeks, compared to 16% and 22% for placebo, respectively.
Moreover, in the PRIME and PRIME2 studies, 60% and 58% of Dupixent-treated patients experienced a clinically meaningful reduction in itch from baseline after 24 weeks, compared to 18% and 20% for placebo, respectively.
“For the first time, patients with prurigo nodularis in Europe have a medicine that can help relieve the burden of itchy and painful nodules covering their skin, which can have a devastating impact on their day-to-day lives, both physically and mentally,” said George Yancopoulos, president and chief scientific officer at Regeneron and a principal inventor of Dupixent.