LONDON (dpa-AFX) - GlaxoSmithKline plc (GSK, GSK.L) and Theravance, Inc. (THRX) announced the submission of regulatory applications in the US and European Union for the once-daily investigational medicine fluticasone furoate 'FF'/vilanterol 'VI' (FF/VI) for patients with chronic obstructive pulmonary disease, or COPD, and a regulatory application for asthma in the European Union.
A Marketing Authorisation Application, or MAA, for FF/VI, with the proposed brand name Relvar, administered by a new dry powder inhaler called Ellipta, has been submitted to the European Medicines Agency for Asthma and COPD.
Further, the company said that a New Drug Application for FF/VI, with the proposed brand name Breo, administered by the Ellipta inhaler, has been submitted to the FDA for COPD.
For asthma, GlaxoSmithKline and Theravance are reviewing the strategy for a future US filing.
Relvar or Breo is an investigational medicine and is not currently approved anywhere in the world.
Copyright RTT News/dpa-AFX