December 08, 2020: “GlaxoSmithKline announced that the US FDA has accepted a regulatory submission seeking approval for the use of its anti-IL5 biologic Nucala (mepolizumab) as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
CRSwNP is an inflammatory condition, characterised by raised eosinophil levels, in which soft tissue growth known as nasal polyps develop in the upper nasal cavity.
Nasal polyps can cause chronic symptoms such as nasal obstruction and discharge. Patients with severe disease may require surgical intervention, however polyps can recur meaning patients go through repeated surgeries that become progressively less effective and more risky.
The submission is based on data from the pivotal SYNAPSE study which explored the effect of Nucala in over 400 patients with CRSwNP.
All patients in the study had a history of previous surgery (approximately one in three had ≥3 surgeries) and needed further surgery due to severe symptoms and increased size of their polyps.
If the submission is approved, Nucala would become the first anti-IL5 biologic to be approved for CRSwNP in the US and the only treatment approved for use in four eosinophil-driven diseases.
Nucala is currently approved in 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 first biologic to be approved for patients aged 12 years and older with hypereosinophilic syndrome (HES).
Nucala is not approved as a treatment for CRSwNP anywhere in the world.
About chronic rhinosinusitis with nasal polyps (CRSwNP)
CRSwNP is a chronic inflammatory disease of the nasal passage linings or sinuses leading to soft tissue growth known as nasal polyps in the upper nasal cavity and is characterised by elevated levels of eosinophils.
The resultant swellings can grow in both nostrils (bilateral) resulting in chronic rhinosinusitis, greatly impacting a patient’s quality of life due to nasal obstruction, loss of smell, facial pain, facial pressure and nasal discharge.
Surgery to remove the polyp tissue may be indicated for severe cases. However, polyps have a strong tendency to reoccur often leading to repeat surgery.”
https://www.gsk.com/en-gb/media/press-releases/fda-accepts-gsk-s-filing-of-nucala-mepolizumab-for-use-in-chronic-rhinosinusitis-with-nasal-polyps/
