The U.S. Food and Drug Administration approved GlaxoSmithKline Plc's new lung drug for treatment of chronic obstructive pulmonary disease (COPD), commonly known as smoker's lung.
However, the inhaled treatment, Anoro Ellipta, will carry a warning that one of its components increase the risk of asthma-related death, FDA said in a statement released on its website. (link.reuters.com/kep55v)
Anoro Ellipta was developed along with U.S. partner Theravance Inc, in which Glaxo owns a 27 percent stake.
The drug combines vilanterol, a long-acting beta-agonist (LABA) that opens the airways, and umeclidinium, a long-acting muscarinic receptor antagonist (LAMA) that improves lung function.
The warning on the drug's label is one of the strongest issued by the regulator and relates to the effect of LABA drugs on asthma patients.
An FDA advisory panel in September voted unanimously in favor of the drug's efficacy but had expressed concerns about its safety profile.
The panel highlighted imbalance in the number of non-fatal heart attacks experienced by patients on Anoro in certain trials, compared with a placebo.
Glaxo and Theravance received FDA approval for another COPD drug, Breo Ellipta, in May. Breo Ellipta, an inhaled combination of vilanterol and corticosteroid fluticasone furoate, was launched in October.
Analysts on average expect Anoro Ellipta to generate annual sales of about $2.65 billion and Breo Ellipta of about $2.22 billion by 2018, according to Thomson Reuters data.
COPD is the third leading cause of death in the United States, according to federal data. The disease, mostly caused by cigarette smoking, can lead to coughing, wheezing, shortness of breath and tightness in the chest.
Novartis AG, AstraZeneca Plc and Boehringer Ingelheim have drugs to treat COPD, but Glaxo's Advair, with sales of about $8 billion a year, is the market leader.
(Reporting by Esha Dey in Bangalore; Editing by Sriraj Kalluvila)