July 29, 2021
Nucala® (mepolizumab), manufactured by GlaxoSmithKline, has received U.S. FDA approval for a new indication to treat chronic rhinosinusitis with nasal polyps (CRSwNP). Under the indication, Nucala is to be used as an add-on maintenance therapy in adults who have had an inadequate response to nasal corticosteroids. The drug is the first interleukin-5 (IL-5) antagonist to receive FDA approval for treatment of nasal polyps.
More than five million people in the United States have CRSwNP, a condition in which inflammation contributes to the development of small growths called polyps in the nasal cavities. These can lead to problems such as uncomfortable pressure, nasal congestion, blocked nasal passages, and loss of smell. In many instances, a type of white blood cell known as an eosinophil is involved in the inflammatory process and growth of the polyps. Nucala is believed to help stop the inflammatory process by blocking the IL-5 amino acid from binding with eosinophils, which may help reduce their numbers.
In a clinical trial, Nucala delivered significant improvement in reduction of nasal polyp size and nasal obstruction compared to placebo. It also reduced the proportion of patients who had nasal polyp surgery by 57% versus placebo and reduced the proportion of patients who needed treatment with systemic corticosteroids. Recommended dosing is 100mg of Nucala given via subcutaneous injection once every four weeks by a healthcare professional.
First FDA approved in 2015, Nucala is also indicated to treat eosinophilic asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.