The US Food and Drug Administration (FDA) is set to review GlaxoSmithKline’s (GSK) Nucala, after accepting a regulatory submission seeking approval for use by patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
GSK’s Nucala (mepolizumab) submission is based on data from the SYNAPSE study, which evaluated the effect of Nucala in over 400 patients with CRSwNP.
Participants involved in this study all had a history of previous surgery and required further surgery due to severe symptoms and increased size of their polyps.
The study met both co-primary endpoints when Nucala was added to standard of care – the treatment demonstrated statistically significant improvements in both the size of nasal polyps at week 52 and in nasal obstruction during weeks 49-52.
According to GSK, if the FDA approves Nucala in this setting, it would become the first anti-IL5 biologic to be approved for CRSwNP in the US.
Nucala is already approved in the US for the treatment of patients with severe eosinophilic asthma aged six years and older and for adults with eosinophilic granulomatosis with polyangiitis (EGPA).
The biologic also recently won approval for patients aged 12 years and older with hypereosinophilic syndrome (HES).
CRSwNP is a chronic inflammatory disease which causes soft tissue growth known as nasal polyps in the upper nasal cavity and is characterised by elevated level of eosinophils.