GlaxoSmithKline (GSK) and Theravance have announced the regulatory submissions for furoate FF/vilanterol VI (FF/VI) to treat chronic obstructive pulmonary disease (COPD) in the US and Europe.
The companies also announced regulatory submission for FF/VI as asthma therapy in the European Union.
FF/VI, which also includes the investigational LAMA/LABA combination umeclidinium bromide/vilanterol,VI monotherapy and MABA, was developed in collaboration with Theravance, as well as GSK's investigational medicines FF monotherapy, UMEC monotherapy and anti-IL5 MAb.
A marketing authorisation application for FF/VI, with the proposed brand name Relvar, administered by a new dry powder inhaler called Ellipta, was submitted as asthma (100/25mcg and 200/25mcg) and COPD (100/25mcg) treatments in the Europe.
A new drug application for FF/VI, with the proposed brand name Breo, administered by the Ellipta inhaler, was submitted for FDA approval as COPD (100/25mcg) treatment.
