The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to nemolizumab (Galderma) for the treatment of pruritus associated with prurigo nodularis.

Prurigo nodularis is a rare skin disease that is characterized by the formation of hard, itchy nodules on the skin. It is commonly associated with intense itching that may lead to severe impairment in quality of life. Nemolizumab is a first-in-class humanized monoclonal antibody that blocks the signaling of interleukin (IL)-31 by targeting against IL-31 receptor alpha.

The designation was based on data from a phase 2 study that evaluated the safety and efficacy of nemolizumab in adults with moderate-to-severe prurigo nodularis (N=70). Results showed nemolizumab was associated with a greater improvement in peak pruritus numeric rating scale score (NRS) at week 4, compared with placebo (primary end point). Moreover, nemolizumab treatment led to significant improvement in skin lesions, as measured by Investigator Global Assessment (IGA). Study findings were recently presented at the 28th Annual Congress of the European Academy of Dermatology and Venereology.

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Dr Thibaud Portal, Galderma Global VP of Prescription medicines, commented: “With the phase 2 study results, we were able to provide substantial clinical evidence supporting the Breakthrough Therapy designation now granted by the US FDA. We are very excited by the prospect of offering a treatment option to doctors, and their patients with prurigo nodularis, where currently there are no registered therapy options.”


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The Company plans to initiate a phase 3 pivotal trial for nemolizumab in adults with prurigo nodularis in 2020. Nemolizumab is also being evaluated in phase 3 trials for the treatment of moderate-to-severe atopic dermatitis.

For more information visit galderma.com.