FDA accepts filing of Nucala in chronic rhinosinusitis with nasal polyps.- GSK

GlaxoSmithKline announced that the FDA has accepted a regulatory submission seeking approval for the use of its anti-IL5 biologic Nucala (mepolizumab) as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).The submission is based on data from the pivotal SYNAPSE study which explored the effect of Nucala in over 400 patients with CRSwNP. All patients in the study had a history of previous surgery (approximately one in three had at least 3 surgeries) and needed further surgery due to severe symptoms and increased size of their polyps. If the submission is approved, Nucala would become the first anti-IL5 biologic to be approved for CRSwNP in the US and the only treatment approved for use in four eosinophil-driven diseases.