GSK PLC (LSE:GSK, NYSE:GSK) announced that Japanese authorities have accepted for review a supplementary new drug application (sNDA) for Nucala (mepolizumab), a treatment for chronic rhinosinusitis with nasal polyps in adult patients.
If approved, Nucala would be the first anti-interleukin-5 biologic available in Japan for the treatment of adults with inadequately controlled chronic rhinosinusitis with nasal polyps, the firm said.
This would be the third indication for mepolizumab in Japan for an IL-5 mediated condition, it said.
The sNDA is based on results of the pivotal phase III Merit trial which studied the efficacy and safety of mepolizumab over a 52-week period in a population of Japanese, Chinese and Russian patients.
In the trial, the co-primary endpoints were met and the efficacy and safety of mepolizumab in the Japanese population were consistent with results from global trials.