GSK GSK plc

By Michael Dabaie

GlaxoSmithKline PLC (GSK) and Innoviva Inc. (INVA) said the European Medicines Agency's Committee for Medicinal Products for Human Use, known as CHMP, issued a positive opinion supporting the use of Trelegy Ellipta in a broader group of patients with moderate to severe chronic obstructive pulmonary disease.

The expanded indication for the once-daily single inhaler triple therapy would enable use by patients not adequately treated by a long-acting muscarinic receptor antagonist and long-acting BETA2-agonist, or LABA, the companies said.

A CHMP positive opinion is one of the final steps before a final decision on the regulatory update is granted by the European Commission.

Trelegy Ellipta was originally approved in the European Union in November 2017 as a maintenance treatment in adult patients with moderate to severe COPD who aren't adequately treated by a combination of an inhaled corticosteroid and a LABA.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

September 21, 2018 08:22 ET (12:22 GMT)

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