FDA panel votes in favor of approval of Glaxo lung drug Anoro
WASHINGTON, Sept 10
WASHINGTON, Sept 10 (Reuters) - An federal advisory panel has recommended that the U.S. Food and Drug Administration approve a drug made by GlaxoSmithKline Plc and Theravance Inc to treat chronic obstructive pulmonary disease.
The panel voted 11-2 to approve the drug, Anoro, an inhaled combination of vilanterol, a long-acting beta-agonist that is designed to open the airways, and umeclidinium, a long-acting muscarinic receptor antagonist, which works to improve lung function.
The FDA is not required to follow the advice of its advisory panels but typically does so.
Analysts expect the drug to generate sales of more than $2 billion a year by 2018 according to the average estimate of six analysts polled by Thomson Reuters.
A decision is expected by Dec. 18. (Reporting by Toni Clarke in Washington; Editing by Carol Bishopric)