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FDA approval of mezopelumab follows the phase 3 SYNAPSE trial in which the anti-Il-5 monoclonal antibody reduced by 57% the need for nasal polyp surgery.
Mepolizumab (Nucala; GlaxoSmithKline [GSK]) an anti-interleukin-5 (IL-5) monoclonal antibody, was approved today by the US Food and Drug Administration (FDA) for treatment of patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The biologic is indicated for add-on maintenance treatment of CRSwNP in adult patients aged ≥18 years who have had inadequate response to nasal corticosteroids.
Mepolizumab is the first anti-IL-5 biologic to be approved for adults with this condition, according to a GSK statement.
“More than 5 million people in the US suffer with chronic rhinosinusitis with nasal polyps and today’s approval provides these patients with the first anti-IL-5 treatment option and an alternative to surgery to help reduce symptoms of this disease, said Hal Barron, MD, chief scientific officer and president R&D, GSK, in the press statement. “GSK is committed to exploring the role of IL-5 inhibition in eosinophil-driven diseases to help address unmet needs of patients.”
CRSwNP is one of a number of inflammatory diseases caused by elevated levels of eosinophils. The related nasal polyps may be bilateral and lead to nasal obstruction, loss of smell, and facial pressure. Surgical removal is indicated in severe cases and repeat surgery is not uncommon.
FDA approval is based on data from randomized placebo-controlled phase 3 SYNAPSE trial in which mepolizumab significantly reduced polyp size vs placebo. All SYNAPSE participants had a history of surgical removal and were in need of further intervention because of severe symptoms. There was a 57% reduction in the proportion of patients requiring surgery in the mepolizumab-treated group vs placebo and the number of patients requiring systemic corticosteroid treatment during the 52-week treatment period was also lower in the mepolizumab group.
Mepolizumab is approved for use in 3 other eosinophil-driven diseases, including severe eosinophilic asthma in patients aged 6 years and older and eosinophilic granulomatosis with polyangiitis (EGPA) in adult patients.
“We welcome the news that mepolizumab will now offer appropriate patients and healthcare providers a novel treatment option and alternative to surgery,” said Tonya Winder, CEO and president, Allergy and Asthma Network and president, Global Allergy and Airways Patient Platform.