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Home Industry News GlaxoSmithKline applies for EU approval of COPD drug

GlaxoSmithKline applies for EU approval of COPD drug

30th April 2013

GlaxoSmithKline has announced that it has applied for European regulatory approval of umeclidinium bromide (UMEC), a promising new therapy for chronic obstructive pulmonary disease (COPD).

A marketing authorisation application has been submitted to the European Medicines Agency for use of the investigational once-daily medicine as a maintenance bronchodilator monotherapy to relieve symptoms among adult COPD patients.

Formerly known as GSK573719, the compound is a long-acting muscarinic antagonist that is administered using GlaxoSmithKline's Ellipta inhaler.

In addition to this monotherapy indication, the manufacturer has filed for European approval of a combination therapy of UMEC and vilanterol, which is intended to be sold under the brand name Anoro.

GlaxoSmithKline also has a number of other late-stage treatments for COPD – developed in partnership with Theravance – within its respiratory portfolio.

These include the fluticasone furoate/vilanterol-based therapy Relvar, which was recommended for clearance by the US Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee earlier this month.ADNFCR-8000103-ID-801578938-ADNFCR

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