FDA green light for Nucala use in adults with chronic rhinosinusitis with nasal polyps

The US Food and Drug Administration has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

This new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, said the drug’s developer, UK pharma major GlaxoSmithKline (LSE: GSK), which notched up Nucala sales of £292 million ($405 million) in the second quarter of 2021, a year-on-year rise of 21%.

CRSwNP accounts for 2%-4% of the US population, affecting more than 5 million people. CRSwNP is one of a variety of diseases arising from inflammation in different tissues associated with elevated levels of a type of white blood cell called eosinophils. It is often characterised by raised eosinophil levels, in which soft tissue growth, known as nasal polyps, develop in the sinuses and nasal cavity. CRSwNP can cause chronic symptoms such as nasal obstruction, loss of smell, facial pressure and nasal discharge.