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GlaxoSmithKline's Nucala given positive opinion by EU's CHMP

Fri, 17th Sep 2021 15:05

(Alliance News) - GlaxoSmithKline PLC on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use has given positive opinions for Nucala, or mepolizumab, being used in three eosinophil-driven diseases.

The three diseases were hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis and chronic rhinosinusitis with nasal polyps. The positive opinion is one of the final steps in the marketing authorisation procedure before approval by the European Commission.

The opinions were based on data from pivotal studies investigating the role of targeting IL-5 inhibition with Nucala in these diseases. Eosinophil-driven diseases are inflammatory conditions associated with elevated levels of eosinophils, a type of white blood cell.

"We are pleased with the CHMP's positive opinions as there are currently limited targeted treatment options available for patients in Europe with eosinophil-driven disease. If approved, mepolizumab would be the first targeted treatment available for use in four of these diseases and would further reinforce its role in targeting the underlying cause of inflammation," said Senior Vice President of Development Christopher Corsico.

Shares in GlaxoSmithKline were marginally higher at 1,395.20 pence on Friday in London.

By Dayo Laniyan; dayolaniyan@alliancenews.com

Copyright 2021 Alliance News Limited. All Rights Reserved.

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