GlaxoSmithKline and Theravance’s Anoro Ellipta gains approval in EU

The European Commission has granted marketing authorization for UK pharma giant GlaxoSmithKline (LSE: GSK) and partner Theravance’s (Nasdaq: THRX) Anoro (umeclidinium/vilanterol) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

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, the Ellipta. The licensed strength in Europe is UMEC/VI 55mcg/22mcg.

$2 billion a year sales forecast by 2018

Late last year, Anoro Ellipta was approved for use in appropriate patients with COPD by both the US Food and Drug Administration (The Pharma Letter December 19, 2013) and Health Canada. Anoro is expected to generate sales of more than $2 billion a year by 2018, according to the average estimate of six analysts polled by Thomson Reuters. Analysts polled by Bloomberg suggest sales could reach $2.7 billion by that year.