Galderma Announces FDA Approval of Nemluvio (nemolizumab) for Prurigo Nodularis
Headline: FDA Approves Galderma's Nemluvio for Prurigo Nodularis
First Approved Monoclonal Antibody for IL-31 Inhibition in Prurigo Nodularis
ZUG, Switzerland, August 13, 2024 - Galderma today announced that the U.S. Food and Drug Administration (FDA) has approved Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis, a chronic inflammatory skin disorder characterized by severe, debilitating itching and painful nodules.
Nemluvio is the first and only approved monoclonal antibody specifically inhibiting the signaling of interleukin-31 (IL-31), a key cytokine involved in the pathogenesis of prurigo nodularis. The FDA approval is based on positive results from two Phase 3 clinical trials, which demonstrated that Nemluvio significantly reduced itch and skin lesions in patients with prurigo nodularis compared to placebo.
The approval of Nemluvio represents a significant advancement in the treatment of prurigo nodularis, offering patients a new and effective option to manage their debilitating symptoms. "We are delighted that the FDA has approved Nemluvio for the treatment of prurigo nodularis," said Andrea Martin, Executive Vice President and Head of Global Dermatology at Galderma. "This approval is a testament to our commitment to delivering innovative solutions to patients with unmet medical needs."
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