GlaxoSmithKline applies for approval of new COPD drug

GlaxoSmithKline and partner Theravance will be applying for European and US regulatory approval of their new once-daily investigational medicine fluticasone furoate/vilanterol (FF/VI).

The drug is being submitted for approval in both territories for use among chronic obstructive pulmonary disease (COPD) patients with a history of exacerbations.

In Europe, the compound will also be assessed for the regular treatment of asthma in adults and adolescents aged 12 years and older, with GlaxoSmithKline and Theravance weighing up strategies for a possible US application in this indication.

FF/VI has previously been referred to as Relovair, but is now receiving a new proposed European brand name of Relvar, while in the US it will be sold under the name Breo.

The drug will be administered via the dry powder inhaler called Ellipta and is yet to be approved by a regulatory body anywhere in the world.

Earlier this week, GlaxoSmithKline announced that it has agreed a deal to acquire long-term collaborative partner Human Genome Sciences following lengthy negotiations.