Galderma has received filing acceptances for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate-to-severe atopic dermatitis in Australia, Singapore, Switzerland, and the United Kingdom, via the Access Consortium framework
The U.S. Food and Drug Administration and European Medicines Agency also accepted filing submissions for nemolizumab for the treatment of prurigo nodularis and atopic dermatitis in February 2024, with U.S. decisions anticipated this year
Further submissions to regulatory authorities in additional countries are ongoing
ZUG, Switzerland--(BUSINESS WIRE)--Galderma today announced that it has received filing acceptances for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate-to-severe atopic dermatitis in Australia, Singapore, Switzerland, and the United Kingdom, whose regulatory authorities are members of the Access Consortium. An approval decision is expected from the consortium next year. Nemolizumab is a therapy specifically inhibiting IL-31 signaling to provide safe and rapid relief from the most burdensome symptom of both skin conditions: itch.1-7
The Access Consortium is a collaborative initiative comprised of regulatory authorities which work together to address shared challenges, sharing knowledge and promoting greater collaboration to make regulatory systems more efficient.8
These acceptances are in addition to those received from the U.S. Food and Drug Administration (FDA) and European Medicines Agency for nemolizumab for the treatment of prurigo nodularis and atopic dermatitis in February 2024. Nemolizumab was also granted Breakthrough Therapy designation by the U.S. FDA in December 2019 for the treatment of pruritus associated with prurigo nodularis, a status reconfirmed in March 2023. The U.S. FDA subsequently granted nemolizumab Priority Review for the treatment of prurigo nodularis; its decisions on prurigo nodularis and atopic dermatitis are anticipated this year. Further submissions to regulatory authorities in additional countries are ongoing.
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“These four new filing acceptances once again reinforce the potential blockbuster status of nemolizumab, which has shown great promise in both prurigo nodularis and atopic dermatitis. With even more filings anticipated this year, we are looking forward to finally bringing this long-awaited therapy to patients with these serious conditions as soon as possible, given the high burden of disease they still face.”
BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA
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