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Galderma, a Swiss-based dermatology company that the United States Food and Drug Administration (FDA) has granted breakthrough therapy designation to its investigational therapy, nemolizumab.
Galderma, a Swiss-based dermatology company, has announced, in a Dec. 9, 2019 press release, that the United States Food and Drug Administration (FDA) has granted breakthrough therapy designation to its investigational therapy, nemolizumab.
Nemolizumab is an investigational monoclonal antibody that works by blocking the signalling of IL-31. The recent therapy designation has been granted for the treatment of pruritus associated with prurigo nodularis, a rare, potentially debilitating, chronic skin condition. The company had presented data from its Phase II study in adult patients, demonstrating the therapy resulted in a greater improvement in peak pruritis Numerical Rating Scale when compared to baseline, and also significantly improved skin lesions.
“With the Phase II study results, we were able to provide substantial clinical evidence supporting the breakthrough therapy designation now granted by FDA,” said Dr. Thibaud Portal, Galderma global vice-president of Prescription medicines, in the press release. “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. We are fully committed to continue driving forward the overall nemolizumab development program.”