Amgen announced new data from the pivotal NAVIGATOR Phase 3 trial demonstrating that tezepelumab reduced exacerbations and improved lung function and nasal symptoms in patients with severe, uncontrolled asthma and comorbid nasal polyps.
The U.S. Food and Drug Administration approved GlaxoSmithKline plc’s Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5, as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The U.S. Food and Drug Administration approved a prefilled syringe for self-injection of the allergic diseases treatment Xolair developed by Novartis and Genentech, a Roche company.
AstraZeneca Plc said the company’s asthma treatment Fasenra for a chronic inflammatory disease of the nasal passage linings, or sinuses, met main goals in a late-stage study.
The U.S. Food and Drug Administration accepted Novartis’ supplemental Biologics License Application for Xolair (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids.
The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.
Sanofi SA’s eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma.
Optinose announced that the U.S. FDA approved the company’s New Drug Application for XHANCE for treating nasal polyps in patients 18 years of age and older.