Glaxo, Theravance File Asthma Drug Application with FDA
30 June 2014 - 10:58PM
Dow Jones News
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
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