GlaxoSmithKline and Theravance apply for EU approval of COPD drug

GlaxoSmithKline and Theravance have submitted a marketing authorisation application to the European Medicines Agency for a new chronic obstructive pulmonary disease (COPD) therapy.

Anoro is a combination of two investigational bronchodilator molecules – the long-acting muscarinic antagonist umeclidinium bromide (UMEC) and the long-acting beta 2 agonist vilanterol – administered via the Ellipta inhaler.

It is intended as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD, with corresponding submissions for the treatment in the US having already been filed.

GlaxoSmithKline and its development partner plan to apply for approval of the drug in a number of additional countries this year, as well as commencing regulatory process for a monotherapy version of UMEC.

These investigational medicines were created in collaboration with Theravance and are not currently approved anywhere in the world.

Last month, GlaxoSmithKline announced top-line six-month primary treatment period results from a phase III study of its new therapy for Fabry disease, which it has developed in collaboration with Amicus Therapeutics.