| Drug Name |
NEMLUVIO® (nemolizumab-ilto) |
| Active Ingredient |
nemolizumab-ilto |
| Date of Approval |
August 12, 2024 |
| Manufacturer |
Galderma Laboratories, L.P. |
| Approval Pathways and Indications |
Approval Pathway: NDA
Indication: NEMLUVIO® is an interleukin-31 receptor antagonist indicated for the treatment of adults with prurigo nodularis (PN). |
| Therapeutic Class |
monoclonal antibody |
| Formulation |
For injection: single-dose prefilled dual chamber pen containing 30 mg of nemolizumab-ilto lyophilized powder and diluent, water for injection. |
| MoA |
Nemolizumab-ilto is a humanized IgG2 monoclonal antibody that inhibits IL-31 signaling by binding selectively to IL-31 RA. IL-31 is a naturally occurring cytokine that is involved in pruritus, inflammation, epidermal dysregulation, and fibrosis. Nemolizumab-ilto inhibited IL-31-induced responses including the release of proinflammatory cytokines and chemokines. |
| Dosing and Administration |
• Patients should complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO®
• Adult Patients Weighing Less Than 90kg: The recommended dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks
• Adult Patients Weighing 90kg or More: The recommended dosage is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks
• Administer NEMLUVIO® by subcutaneous injection
• NEMLUVIO® must be reconstituted prior to administration |
| Administered by self or by HCP |
Administered by HCP |
| Place in Therapy |
NEMLUVIO® is the first approved monoclonal antibody specifically inhibiting the signaling of IL-31, a neuroimmune cytokine that drives multiple disease mechanisms in PN. Prurigo nodularis is an underdiagnosed neuroimmune skin disease affecting up to 181,000 people in the United States. This condition is characterized by chronic itching, skin nodules covering large body areas, and poor sleep quality. Topical steroids have been the standard of care for PN, bringing with them the potential for severe side effects when used over long stretches of time.
The FDA has also accepted for review the Biologics License Application for NEMLUVIO® for the treatment of moderate-to-severe atopic dermatitis, with a decision anticipated later in 2024. |
| Expected Market Launch Date |
Data Unavailable |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
Data Unavailable |
| Product Discontinuation |
N/A |
| Clinical Trials |
NEMLUVIO® has been approved following positive results from the phase III OLYMPIA clinical trials, which represent the largest trial program conducted for prurigo nodularis to date. These trials demonstrated that NEMLUVIO®, administered subcutaneously every four weeks, led to significant and clinically meaningful improvements in both itch and skin nodules. Notably, rapid reductions in itch were observed as early as Week 4.
In the OLYMPIA 1 and OLYMPIA 2 trials, involving over 500 patients, NEMLUVIO® was shown to be highly effective. By Week 16, 56% and 49% of patients in OLYMPIA 1 and 2 respectively, achieved at least a four-point reduction in itch intensity, compared to just 16% in the placebo groups (p<0.001). Additionally, at Week 4, 41% of patients in both OLYMPIA trials experienced a significant reduction in itch intensity, compared to 6% and 7% in the placebo groups (p<0.001).
The trials also evaluated the impact of NEMLUVIO® on skin nodules, with 26% and 38% of patients reaching clearance or near-clearance of skin nodules by Week 16, compared to 7% and 11% in the placebo groups (p<0.001). Furthermore, 50% and 52% of NEMLUVIO®-treated patients reported at least a four-point reduction in sleep disturbance by Week 16, compared to 12% and 21% in the placebo groups (p<0.001).
Overall, NEMLUVIO® met all key secondary endpoints, confirming its ability to rapidly reduce both itch and sleep disturbance within four weeks of treatment initiation. The drug was generally well tolerated, with a safety profile consistent with previous phase II trials and similar across the two phase III trials. |
| Sources |
Fierce Pharma. Itching for Leadership in Therapeutic Dermatology: Galderma Wins FDA Nod for Nemluvio to Treat Prurigo. Accessed August 13, 2024. Available from: https://www.fiercepharma.com/pharma/itching-leadership-therapeutic-dermatology-galderma-wins-fda-nod-nemluvio-treat-prurigo
Galderma. Galderma Receives US FDA Approval for Nemluvio (Nemolizumab) for Adult Patients Living with Prurigo Nodularis. Accessed August 13, 2024. Available from: https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo
Galderma. Nemluvio (Nemolizumab) Product Information. Accessed August 13, 2024. Available from: https://www.galderma.com/sites/default/files/2024-08/Nemluviouspippi0812.pdf
Galderma. Galderma Receives US FDA Approval for Nemluvio (Nemolizumab) for Adult Patients Living with Prurigo Nodularis. Accessed August 13, 2024. Available from: https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo
Drugs.com. FDA Approves Nemluvio (Nemolizumab) for Adult Patients with Prurigo Nodularis. Accessed August 13, 2024. Available from: https://www.drugs.com/newdrugs/fda-approves-nemluvio-nemolizumab-adult-patients-prurigo-nodularis-6351.html |