FDA approves Nucala for chronic rhinosinusitis with nasal polyps
GlaxoSmithKline announced that the FDA has approved Nucala as a treatment for adults who have chronic rhinosinusitis with nasal polyps.
Nucala (mepolizumab) is a monoclonal antibody that inhibits interleukin-5. It is approved as an “add-on maintenance treatment” of chronic rhinosinusitis with nasal polyps for patients who have an insufficient response to nasal corticosteroids, according to a press release.
“More than 5 million people in the U.S. suffer with chronic rhinosinusitis with nasal polyps and [this] approval provides these patients with the first anti-IL-5 treatment option and an alternative to surgery to help reduce symptoms of this disease,” Hal Barron, MD, chief scientific officer and president of research and development at GlaxoSmithKline (GSK), said in the release. “GSK is committed to exploring the role of IL-5 inhibition in eosinophil-driven diseases to help address unmet needs of patients.”
The FDA’s decision is based on data from the SYNAPSE study, which investigated the effect of mepolizumab compared with placebo in 400 patients with chronic rhinosinusitis with nasal polyps. Patients who received mepolizumab for 52 weeks achieved significant improvements in reducing the size of nasal polyps and obstruction, according to the release. Researchers found that mepolizumab correlated with a 57% reduction in the number of patients who had surgery due to polyps or severe symptoms (HR = 0.43; 95% CI, 0.25-0.76). Also, fewer patients who received the drug vs. placebo required systemic corticosteroid use during the study period.
The FDA previously approved mepolizumab for severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome. The drug is now the first anti-IL-5 biologic approved for adults with chronic rhinosinusitis with nasal polyps, according to the release.