GSK PLC on Friday said a new drug application for its monoclonal antibody mepolizumab has been accepted for review by the Japanese government.

Shares in GSK were marginally down at 1,389.60 pence in London early on Friday.

GSK said the Japanese Ministry of Health, Labour & Welfare has accepted for review its supplementary new drug application for mepolizumab, brand name Nucala, as a treatment for chronic rhinosinusitis with nasal polyps, or eosinophilic chronic rhinosinusitis, in adults.

GSK made the application based on results from its phase three Merit trial, which studied Nucala’s safety and efficacy over one year in patients with ‘inadequately controlled’ chronic rhinosinusitis. It also used data from the global phase three Synapse trial, which tested the antibody against a placebo.

GSK said if Nucala is approved, it will become the first anti-IL-5 biologic for adult chronic rhinosinusitis patients available in Japan. It is already approved there to treat bronchial asthma in children aged six years and older, as well as refractory asthma and eosinophilic granulomatosis with polyangiitis in adults.

Chronic rhinosinusitis is caused by chronic inflammation of the nasal lining, with symptoms including nasal congestion, facial pain and a decreased sense of smell, and affects an estimated 2 million people in Japan. Approximately 10% of those patients may require surgery to treat nasal polyps, or soft tissue growth in the sinuses and nasal cavity.

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