LONDON (Alliance News) - GlaxoSmithKline PLC and Theravance Inc said Monday it had submitted a supplemental new drug application to the US Food and Drug administration for the combined treatment furoate and vilanterol in the treatment of asthma.
The combined treatment is for patients aged 12 or older, under the brand name Breo Ellipta. The application is seeking approval for two dose regimens, a 100/25 microgram and a 200/25 microgram dose regimen.
Breo Ellipta has been approved for a 100/25 microgram dose by the FDA since May 2013 for the treatment of chronic obstructive pulmonary disease.
Shares in Glaxo were trading down 0.7% at 1,562.50 pence Monday afternoon.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
Copyright 2014 Alliance News Limited. All Rights Reserved.