Dec 18 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
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
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