European Commission approves first drug for prurigo nodularis

The European Commission (EC) has extended the marketing authorization for Dupixent^® (dupilumab) in the European Union (EU), to treat adults with moderate to severe nodular prurigo (PN) who are candidates for systemic therapy, making it the first and only targeted medicine for the disease in Europe and in the United States.

The EC decision is based on data from two phase III trials, PRIME and PRIME2, evaluating the efficacy and safety of Dupixent^® (PRIME n=75; PRIME2 n=78) in 311 adults with non-placebo-controlled PN (PRIME n=76; PRIME2 n=82).

Commenting on the EC approval, Dr. Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi, said: “In trials, patients treated with Dupixent^® experienced significant improvements in key features of the condition, such as reduced itchiness and clearer skin, as well as broader impacts on their daily lives.

Phase III trial data that formed the basis of CE approval

The primary endpoint of both trials assessed the proportion of patients with a clinically meaningful improvement in itch from baseline (measured by a reduction of ≥ 4 points on the Worst Itch Numerical Rating Scale [WI-NRS] on a scale of 0 to 10) at 24 and 12 weeks, respectively.

Additional endpoints included the proportion of patients with clear or almost clear skin of nodules at 24 weeks (measured by a score of 0 or 1 on the PN-Stage Investigator’s Global Assessment [IGA PN-S] on a scale of 0 to 4), the proportion of patients who achieved a clinically meaningful response in both the WI-NRS and IGA PN-S, the improvement from baseline in health (measured by the Dermatology Life Quality Index [DLQI] on a scale of 0 to 30), improvement from baseline in skin pain (measured by a numerical rating scale of 0 to 10), and improvement from baseline in symptoms of anxiety and depression (measured by hospital anxiety and depression scale [HADS] from 0 to 42).

Positive data from prurigo nodularis trials demonstrated:

• At 12 weeks, 44% and 37% Dupixent^® patients experienced a clinically meaningful reduction in itch compared to 16% and 22% for placebo, respectively
• At 24 weeks, the improvement was even more marked, with about three times more Dupixent^® patients (60% and 58%) experiencing a clinically meaningful reduction in itch from baseline, compared to placebo (18% and 20%).

More than double Dupixent^® patients (48% and 45%) also achieved clear or almost clear skin at 24 weeks, compared to placebo (18% and 16%). Dupixent^® also significantly improved health-related quality of life, while reducing measures of skin pain and anxiety/depressive symptoms from baseline to 24 weeks compared to placebo.

The safety results from the trials were generally consistent with Dupixent’s known safety profile^® in its approved indications, with the most common side effects across all indications including injection site reactions, conjunctivitis, allergic conjunctivitis, arthralgia, oral herpes and eosinophilia. Adverse events (AEs) more frequently observed in PN with Dupixent^® versus placebo included conjunctivitis (four percent versus one percent).

tricked^® for nodular prurigo

tricked^®, jointly developed by Sanofi and Regeneron, is a fully human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) pathway signaling and is not an immunosuppressant . It is given by injection at 300 mg every two weeks, under the skin (subcutaneous injection) at different injection sites, after a loading dose.

tricked^® has been granted an additional one-year marketing protection in the EU, based on the recommendation of the Committee for Medicinal Products for Human Use (CHMP) that the medicine provides significant clinical benefit over existing therapies for patients with NP.

Dr. George D Yancopoulos, PhD, President and Chief Scientific Officer of Regeneron concluded: “Dupixent^® is now approved for his second skin condition and fourth condition overall.