Galderma’s nemolizumab has received filing acceptances for prurigo nodularis (PN) and atopic dermatitis (AD) in Australia, Singapore, Switzerland, and the United Kingdom.
These countries or regulatory authorities are members of the Access Consortium. An approval decision is expected from the consortium next year.
Nemolizumab inhibits interleukin (IL)-31 signaling to provide relief from itch.
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 PN and AD 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 PN, a status reconfirmed in March 2023.
The U.S. FDA subsequently granted nemolizumab Priority Review for the treatment of prurigo nodularis; its decisions on PN and AD are anticipated this year.
Further submissions to regulatory authorities in additional countries are ongoing.
The regulatory submissions of nemolizumab in prurigo nodularis are based on data from the phase III OLYMPIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks in patients with PN . Both trials in the OLYMPIA program met all primary and key secondary endpoints. Results demonstrated nemolizumab’s ability to rapidly improve itch, clear skin nodules and reduce sleep disturbance, with sustained improvements for up to one year.
The regulatory submissions of nemolizumab in AD are based on data from the phase III ARCADIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks in adolescents and adults with moderate-to-severe AD. Both trials in the ARCADIA program met all primary and key secondary endpoints. Results showed that nemolizumab clinically improved skin lesions and rapidly improved itch and sleep disturbance.
