Sept 6 (Reuters) - An experimental drug to treat chronicobstructive pulmonary disease made by GlaxoSmithKline Plc and Theravance Inc appears to work, but itssafety data are not entirely conclusive, according to medicalreviewers for the U.S. Food and Drug Administration.
The reviewers posted their opinion on the FDA's website onFriday ahead of a meeting next Tuesday of an outside panel ofmedical experts, who will discuss the drug and recommend whetherthe agency should approve it. The FDA is not required to followthe advice of its expert panels but typically does so.
The FDA's reviewers said that while the safety databasesubmitted by GSK is fairly large, it is "not entirelyconclusive, particularly in regards to cardiovascular safety."
The drug, Anoro, is an inhaled combination of vilanterol, along-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)
Astrazeneca (AZN)
Glaxosmithkline (GSK)
