Nemluvio Approved for Prurigo Nodularis
On August 12, 2024, the U.S. Food and Drug Administration (FDA) approved Galderma’s Nemluvio® (nemolizumab-ilto), an interleukin-31 (IL-31) receptor antagonist. It is indicated for the treatment of adults with prurigo nodularis (PN). It will be available as 30mg single-dose pre-filled pens for subcutaneous (SC) injection. After completing all age-appropriate immunizations, adults weighing less than 90kg should receive an initial dose of 60mg [two 30mg SC injections], followed by 30mg every four weeks. The recommended initial dose for adults weighing more than 90kg is 60mg, followed by 60mg every four weeks. The launch is expected within the next 48 hours. Pricing information is not yet available. For full prescribing information, see here.
At a Glance
- Brand Drug: Nemluvio (nemolizumab-ilto)
- Manufacturer: Galderma
- Date Approved: August 12, 2024
- Indication: for the treatment of adults with prurigo nodularis (PN)
- Dosage Forms Available: single-dose pre-filled dual chamber pens containing 30mg of nemolizumab-ilto lyophilized powder and diluent (water for injection) for SC injection
- Launch Date: Within the next 48 hours
- Estimated Annual Cost: Not available at this time
- PN is a chronic inflammatory skin disease in which an extremely itchy, symmetrically distributed rash appears most commonly on the arms, legs, upper back, and/or abdomen. The itch associated with PN is so severe that it often interferes with sleep and psychological well-being. It is commonly associated with other diseases such as atopic dermatitis or any dermatoses associated with chronic pruritus.
- It is estimated that PN affects up to 181,000 Americans and is considered to be an under-diagnosed condition with an unknown exact cause. However, since Nemluvio targets IL-31, a neuroimmune cytokine, it could be a mechanism that fuels the disease.
- PN is typically treated with corticosteroid injections, topical corticosteroids, and antihistamines. Sanofi/Regeneron’s Dupixent® (dupilumab) received an expanded indication for adults with PN in September 2022.
- Approval of Nemluvio was based on results from the Phase III OLYMPIA I and OLYMPIA II clinical studies. At week 16, 56% and 49% of treated patients in the two studies, respectively, achieved at least a four-point reduction in itch intensity compared to 16% in both placebo groups. Nemluvio was also effective in improving skin clearance and reducing sleep disturbance.
- The most common side effects of Nemluvio include headache and skin rash. Nemluvio can also cause hypersensitivity reactions and individuals should not receive live vaccines during its use.
- Nemluvio was approved with Priority Review; it also had a Breakthrough Therapy Designation.