8th Dec 2020 14:30
(Alliance News) - GlaxoSmithKline PLC on Tuesday said the US Food and Drug Administration has accepted its submission for the use of its anti-IL5 biologic Nucala, or mepolizumab as a treatment for patients with chronic rhinosinusitis with nasal polyps, or CRSwNP.
CRSwNP is an inflammatory condition where 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 cases of the disease often have repeated surgeries as polyps can reoccur.
If approved by the FDA, Nucala would be the first anti-IL5 biologic to be authorised for treating CRSwNP and the only treatment in the US for use in four eosinophil-driven diseases.
GSK said its submission is based on data from a study it conducted called Synapse, which explored the effect of Nucala in more than 400 CRSwNP patients. All patients who took part in the study had a history of previous surgery and needed further surgery due to severe symptoms and increased size of their polyps.
Shares in GSK were down 0.9% at 1,385.40 pence in London on Tuesday.
By Zoe Wickens; [email protected]
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