GlaxoSmithKline Receives European Approval for COPD Drug Anoro

By Pharma News - DCAT Publisher

May 8, 2014

GlaxoSmithKline plc  (GSK) and Theravance, Inc. have been granted marketing authorization by the European Commission for Anoro (umeclidinium/vilanterol) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).Theravance is focused on the discovery, development, and commercialization of small-molecule medicines across a number of therapeutic areas, including respiratory disease, bacterial infections, and central nervous system pain.

Anoro is a once-daily combination treatment comprising two bronchodilators, umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2 agonist (LABA), in a single inhaler, Ellipta. The licensed strength in Europe is UMEC/VI 55mcg/22mcg.

Under a 2002 LABA collaboration agreement with GSK, Theravance is obligated to make a milestone payment to GSK of
$15 million (USD) following marketing authorization for UMEC/VI by the European Commission. A further $15 million payment to GSK will follow the launch of UMEC/VI in Europe. 
The first launch is expected to take place in Europe in the second/third quarters of 2014 with additional launches to follow thereafter

Since December 2013, Anoro Ellipta has been licensed for use in appropriate patients with COPD in several countries, including the US and Canada. Regulatory applications for UMEC/VI have been submitted and are undergoing assessment in a number of other countries, including Japan.

Source: GSK