NEMLUVIO (nemolizumab) - Prurigo nodularis

The clinical benefit of NEMLUVIO 30 mg (nemolizumab) solution for injection in pre-filled pen is substantial in the MA indication.

Considering:

• the partially met medical need in adults with prurigo nodularis in the event of inadequate response to topical treatments, and the concomitant development with DUPIXENT (dupilumab) in prurigo nodularis (PN),
• evidence in two phase 3, randomised, double-blind studies (OLYMPIA 1 and 2) of the superiority of nemolizumab compared to placebo, with a substantial and clinically relevant effect size on:
  • pruritus, assessed by the percentage of patients with a reduction in PP-NRS ≥ 4 at week 16 and at week 4,
  • the overall assessment of PN nodules by the IGA 0 response (clear) or 1 (almost clear) with an improvement ≥ 2 points compared to baseline at week 16,
  • sleep quality, assessed by the percentage of patients with a reduction in SD-NRS ≥ 4 at week 16 and at week 4,
• the absence of a robust assessment of quality of life, which is significantly impacted by the symptoms of prurigo nodularis, although favourable effects on pruritus and sleep quality have been demonstrated,
• the absence of long-term comparative efficacy data, despite the fact that the disease is chronic; the efficacy endpoints have been assessed after a maximum of 16 weeks, although exploratory non-comparative results suggest maintenance of the clinical response up to week 124,
• the medium-term safety profile (124 weeks) of nemolizumab in studies in PN, primarily marked by the development of headaches, eczematous reactions (atopic dermatitis, eczema and nummular eczema) and exacerbation of pre-existing asthma (primarily in patients with a body weight of over 90 kg),

The Committee deems that NEMLUVIO 30 mg (nemolizumab) solution for injection in pre-filled pen provides a moderate clinical added value (CAV III) in the treatment of adults with moderate to severe prurigo nodularis who are candidates for systemic therapy, in the same way as DUPIXENT (dupilumab).