Nucala to treat chronic rhinosinusitis with nasal polyps: GSK submitted for regulatory approval to FDA

GlaxoSmithKline (GSK) announced that approval for the utilization of its anti-IL5 biologic Nucala (mepolizumab) as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) is acepted by US Food and Drug Administration (FDA)

CRSwNP is an inflammatory condition, characterised by raised eosinophil levels, during which soft tissue growth referred to as nasal polyps develop within the upper cavity . Nasal polyps can cause chronic symptoms like nasal obstruction and discharge. Patients with severe disease may require surgical intervention, however polyps can recur meaning patients undergo repeated surgeries that become progressively less effective and more risky.

The submission is predicated on data from the pivotal SYNAPSE study which explored the effect of Nucala in over 400 patients with CRSwNP. All patients within the study had a history of previous surgery (approximately one in three had =3 surgeries) and needed further surgery thanks to severe symptoms and increased size of their polyps.

If the submission is approved, Nucala would become the primary anti-IL5 biologic to be approved for CRSwNP within the US and therefore the only treatment approved to be used in four eosinophil-driven diseases.

Nucala is currently approved within the US for patients with severe eosinophilic asthma aged six years and older and for adults with eosinophilic granulomatosis with polyangiitis (EGPA). It also recently became the primary biologic to be approved for patients aged 12 years and older with hypereosinophilic syndrome (HES). Nucala isn’t approved as a treatment for CRSwNP anywhere within the world.

CRSwNP may be a chronic disease of the nasal passage linings or sinuses resulting in soft tissue growth referred to as nasal polyps within the upper cavity and is characterised by elevated levels of eosinophils. The resultant swellings can grow in both nostrils (bilateral) leading to chronic rhinosinusitis, greatly impacting a patient’s quality of life thanks to nasal obstruction, loss of smell, facial pain, facial pressure and nasal discharge. Surgery to get rid of the polyp tissue could also be indicated for severe cases. However, polyps have a robust tendency to reoccur often resulting in repeat surgery.

First approved in 2015 for severe eosinophilic asthma (SEA), mepolizumab is that the first-in-class antibody that targets IL-5. it’s believed to figure by preventing IL-5 from binding to its receptor on the surface of eosinophils, restoring blood eosinophils to more normal levels. The mechanism of action for mepolizumab has not been definitively established.

Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils. it’s been studied in over 3,000 patients in 26 clinical trials across variety of eosinophilic indications and has been approved under the name Nucala within the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with SEA.