GSK announces CNMPA accepted review the new drug application for Nucala

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.