US FDA approves GSK/Theravance’s Anoro Ellipta for COPD

The US Food and Drug Administration late yesterday approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder), from UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX).

The drug, which is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, could generate sales of $1.2 billion in 2016, according to the average of eight analysts’ estimates compiled by Bloomberg, and $2.7 billion by 2018.

Darrell Baker, senior vice president and head of GSK Global Respiratory Franchise, said: “We believe Anoro Ellipta will be an important treatment option for appropriate patients with COPD. It is the first combination product approved in the USA that delivers two once-daily bronchodilators in a single inhaler. This approval is a significant achievement for GSK.”