LONDON (Alliance News) - GlaxoSmithKline PLC said Friday that Incruse, a treatment for chronic obstructive pulmonary disease, had been recommended for marketing authorisation by the European Medicines Agency's committee for Medical Products for Human Use, a key step in getting approval for the drug.
"The CHMP's decision brings us a step closer to offering physicians a further once-daily treatment choice for appropriate COPD patients," said Glaxo's President of Pharmaceuticals Research and Development Patrick Vallance in a statement. "We look forward to a final decision from the European Commission in the next few months."
Incruse is the proposed brand name of umeclidinium.
Glaxo said that Phase 3 clinical trials included both the investigation of umeclidinium as a monotherapy, as well as in a combined therapy with drug vilanterol under the proposed brand name Anoro.
On Thursday Anoro was also recommended for marketing authorisation by the committee. Glaxo expects a final decision on marketing authorisation for both Anoro and Incruse from the European Commission during the second quarter of 2014.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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Glaxosmithkline (GSK)