GSK (GSK) announced that the China National Medical Products Administration, CNMPA, has accepted for review the new drug application for the use of Nucala, a monoclonal antibody that targets interleukin-5, as add-on maintenance treatment for patients with chronic obstructive pulmonary disease, COPD, with an eosinophilic phenotype. Nucala’s application was supported by results from the positive Phase III MATINEE trial which showed a significant and clinically meaningful reduction in rate of moderate/severe exacerbations with Nucala compared to placebo. These data indicate that Nucala, in addition to inhaled maintenance therapy, offers a clinically meaningful benefit to a patient population in need of treatments to reduce their risk of exacerbations. If approved, Nucala could be the first approved biologic with monthly dosing for patients with COPD.
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