GSK Gsk Plc

By Tapan Panchal

LONDON--GlaxoSmithKline PLC (GSK.LN) and Theravance Inc. (THRX) have submitted a supplemental new drug application to the U.S. Food and Drug Administration for a drug used for treatment of asthma in patients aged 12 years and older.

The British pharmaceutical company said Monday that the application is for a fixed-dose combination of fluticasone furoate and vilanterol as a once-daily treatment for asthma. The application has been filed under the brand name of Breo Ellipta and is seeking approval for two dose regimens, 100/25 micrograms and 200/25 micrograms.

GSK said the filing is based upon data from a comprehensive clinical development program.

Shares of GSK at 1111 GMT are trading 0.6% lower at 1563 pence.

Write to Tapan Panchal at tapan.panchal@wsj.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires