FDA Approves Mepolizumab for Patients with Chronic Rhinosinusitis with Nasal Polyps

The US Food and Drug Administration (FDA) approved the monoclonal antibody mepolizumab (Nucala) as a suitable treatment for patients with chronic rhinosinusitis with nasal polyps.

The biologic, which targets interleukin-5 (IL-5) proteins, will be used as add-on maintenance treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age or older who had inadequate responses to nasal corticosteroids.

Mepolizumab is the first anti-IL-5 biologic to be approved for adults with this condition.

Chronic rhinosinusitis with nasal polyps has affected more than 5 million people in the United States, which is roughly 2-4% of the national population. It is associated with development of polyps located within the nasal cavity, as well as inflammation in tissues associated with eosinophils.

Mepolizumab has achieved significant improvement regarding reducing nasal polyp size and nasal obstruction. Additionally, the data collected from the SYNAPSE study indicated a 57% reduction in the proportion of patients who had surgery in the mepolizumab group in comparison to the placebo group.

Mepolizumab had previously been approved for use in 3 other eosinophilic driven diseases, including severe eosinophilic asthma in patients aged 6 years and older and eosinophilic granulomatosis with polyangiitis (EGPA) in adult patients.

In a statement from pharmaceutical company GlaxoSmithKline, Tonya Winders, CEO & President, Allergy and Asthma Network (AAN) and President of Global Allergy and Airways Patient Platform (GAAPP), expressed her excitement on the new FDA approval.

“We welcome the news that mepolizumab will now offer appropriate patients and healthcare providers a novel treatment option and alternative to surgery,” Winders said.