Safety data on Glaxo COPD drug inconclusive -FDA staff
Sept 6 (Reuters) - An experimental drug to treat chronic obstructive pulmonary disease made by GlaxoSmithKline Plc and Theravance Inc appears to work, but its safety data are not entirely conclusive, according to medical reviewers for the U.S. Food and Drug Administration.
The reviewers posted their opinion on the FDA's website on Friday ahead of a meeting next Tuesday of an outside panel of medical experts, who will discuss the drug and recommend whether the agency should approve it. The FDA is not required to follow the advice of its expert panels but typically does so.
The FDA's reviewers said that while the safety database submitted by GSK is fairly large, it is "not entirely conclusive, particularly in regards to cardiovascular safety."
The drug, Anoro, is 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.
(Reporting by Toni Clarke in Washington; Editing by Gerald E. McCormick)