European Commission approves first medicine for prurigo nodularis
Posted: 15 December 2022 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
Dupixent®, the first and only targeted medicine for prurigo nodularis has been approved by the EC for adults with a moderate-to-severe form of the condition.
The European Commission (EC) has expanded the marketing authorisation for Dupixent® (dupilumab) in the European Union (EU), to treat adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy, making it the first and only targeted medicine for the condition in Europe and the US.
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 uncontrolled PN compared to placebo (PRIME n=76; PRIME2 n=82).
Commenting on the EC’s approval, Dr Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi noted: “In the 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.”
Phase III trial data that formed the basis of the EC’s approval
The primary endpoint in both trials evaluated the proportion of patients with clinically meaningful improvement in itch from baseline (measured by a ≥4-point reduction in Worst-Itch Numeric Rating Scale [WI-NRS] on a 0-10 scale) 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 Investigator’s Global Assessment PN-Stage [IGA PN-S] on a 0-4 scale), the proportion of patients who achieved a clinically meaningful response in both WI-NRS and IGA PN-S, improvement from baseline in health-related quality of life (measured by the Dermatology Life Quality Index [DLQI] on a 0-30 scale), improvement from baseline in skin pain (measured by a Numerical Rating Scale from 0-10), and improvement from baseline in symptoms of anxiety and depression (measured by the Hospital Anxiety and Depression Scale [HADS] from 0-42).
Positive data from the prurigo nodularis trials demonstrated:
- At 12 weeks, 44 percent and 37 percent of Dupixent® patients experienced a clinically meaningful reduction in itch, compared to 16 percent and 22 percent for placebo, respectively
- At 24 weeks, the improvement further increased, with approximately three times as many Dupixent® patients (60 percent and 58 percent) experiencing a clinically meaningful reduction in itch from baseline, compared to placebo (18 percent and 20 percent).
More than double as many Dupixent® patients (48 percent and 45 percent) also achieved clear or almost clear skin at 24 weeks, compared to placebo (18 percent and 16 percent). Dupixent® also significantly improved health-related quality of life, while reducing measures of skin pain and symptoms of anxiety/depression from baseline at 24 weeks compared to placebo.
The safety results of the trials were generally consistent with the known safety profile of Dupixent® in its approved indications, with the most common side effects across indications including injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia. Adverse events (AEs) more commonly observed in PN with Dupixent® compared to placebo included conjunctivitis (four percent versus one percent).
Dupixent® for prurigo nodularis
Dupixent®, jointly developed by Sanofi and Regeneron, is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. It is administered by injection at 300mg every two weeks, under the skin (subcutaneous injection) at different injection sites, following a loading dose.
Dupixent® was granted an additional one-year marketing protection in the EU, based on recommendation by the Committee for Medicinal Products for Human Use (CHMP) that the medicine brings significant clinical benefit compared to existing therapies for patients with PN.
Dr George D Yancopoulos, PhD, President and Chief Scientific Officer at Regeneron concluded: “Dupixent® is now approved for its second dermatological disease and fourth disease overall.”