The sJNDA is based on the data from the Phase 3 MERIT trial that examined the efficacy and safety of Nucala over 52 weeks and the Phase 3 SYNAPSE study which examined the impact of mepolizumab versus placebo
GSK House in London, UK. (Credit: GSK plc.)
GSK reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted its supplementary new drug application (sJNDA) for Nucala (mepolizumab) to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients.
Nucala is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), responsible for the maturation and activation of eosinophils.
The sJNDA is based on the data from the global Phase 3 MERIT trial that examined the efficacy and safety of Nucala over 52 weeks in a population of Japanese, Chinese, and Russian patients with inadequately controlled CRSwNP or eosinophilic chronic rhinosinusitis (ECRS).
The application was also based on the Phase 3 SYNAPSE study, which examined the impact of mepolizumab versus placebo in more than 400 patients with CRSwNP.
Upon approval, the antibody-drug will become the first anti-IL-5 biologic licensed for adult patients in Japan with insufficiently managed CRSwNP, GSK said.
Nucala has received approval in Japan as a treatment for adults with refractory asthma whose symptoms are insufficiently controlled by standard therapy.
It is also authorised for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), who are not adequately responding to the current therapy for their condition.
The primary endpoints of the MERIT trial were variation from baseline in total endoscopic nasal polyp score at week 52 and change from baseline in mean nasal obstruction visual analogue scale (VAS) score during the four weeks before week 52.
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.
In July 2021, the British pharmaceutical company secured US Food and Drug Administration (FDA) approval for Nucala to treat adults with CRSwNP.