FDA Approves Mepolizumab for Adults With Chronic Rhinosinusitis With Nasal Polyps

The FDA has approved the monoclonal antibody mepolizumab (Nucala, GlaxoSmithKline plc), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Mepolizumab works by targeting interleukin-5 (IL-5) and is the first anti-IL-5 biologic to be approved by the FDA for use in adult patients with CRSwNP in the United States.

This approval is a new indication for mepolizumab, making it an add-on maintenance treatment for adult patients with CRSwNP 18 years of age and older who have shown a previous inadequate response to nasal corticosteroids. Mepolizumab has also been previously approved for use in 3 other eosinophilic-driven diseases, the first of which was severe eosinophilic asthma among pediatric patients 6 years of age and older.

CRSwNP, which arises from inflammation in different tissues, currently affects more than 5 million people in the United States. This inflammation is also associated with increased levels of the white blood cell eosinophils. With their eosinophil levels raised, patients with CRSwNP can develop nasal polyps in the sinuses and nasal cavity. CRSwNP can also lead to chronic symptoms of nasal obstruction, loss of smell, facial pressure, and nasal discharge.

“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,” Hal Barron, MD, chief scientific officer and president R&D, GSK, in a press release.

Officials at the FDA based the approval of mepolizumab on the results of the SYNAPSE study, which investigated the effect of mepolizumab against the placebo in more than 400 patients with CRSwNP. The data showed that mepolizumab significantly improved the reduction in size of nasal polyps and nasal obstruction.

During the study, the patients received the standard care for CRSwNP. All patients included in the study had a history of prior surgery—approximately 1 in 3 had 3 or more surgeries—and needed additional surgery due to the severity of their symptoms and increased size of their polyps.

The results from the SYNAPSE study demonstrated a 57% reduction in the proportion of patients who had surgery in the group treated with mepolizumab versus placebo [HR=0.43 (95% CI 0.25, 0.76)]. Additionally, the proportion of patients who required treatment with a systemic corticosteroid in week 52 of the treatment period was lower in patients who received mepolizumab.

“Patients with chronic rhinosinusitis with nasal polyps experience unpleasant symptoms across a range of severities. As there have been limited treatment options, particularly for those patients with severe disease, they may rely on oral steroids and recurrent surgery to manage their condition,” said Tonya Winders, CEO and president, Allergy and Asthma Network (AAN) and president of Global Allergy and Airways Patient Platform, in the press release. “We welcome the news that mepolizumab will now offer appropriate patients and health care providers a novel treatment option and alternative to surgery.”

REFERENCE

GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps. GlaxoSmithKline; July 29, 2021. [email]. Accessed July 29, 2021.