Dec 18 (Reuters) - The U.S. Food and Drug Administrationapproved GlaxoSmithKline Plc's new lung drug fortreatment of chronic obstructive pulmonary disease (COPD),commonly known as smoker's lung.
However, the inhaled treatment, Anoro Ellipta, will carry awarning that one of its components increase the risk ofasthma-related death, FDA said in a statement released on itswebsite. ()
Anoro Ellipta was developed along with U.S. partnerTheravance 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-actingmuscarinic receptor antagonist (LAMA) that improves lungfunction.
The warning on the drug's label is one of the strongestissued by the regulator and relates to the effect of LABA drugson asthma patients.
An FDA advisory panel in September voted unanimously infavor of the drug's efficacy but had expressed concerns aboutits safety profile.
The panel highlighted imbalance in the number of non-fatalheart attacks experienced by patients on Anoro in certaintrials, compared with a placebo.
Glaxo and Theravance received FDA approval for another COPDdrug, Breo Ellipta, in May. Breo Ellipta, an inhaled combinationof vilanterol and corticosteroid fluticasone furoate, waslaunched in October.
Analysts on average expect Anoro Ellipta to generate annualsales of about $2.65 billion and Breo Ellipta of about $2.22billion by 2018, according to Thomson Reuters data.
COPD is the third leading cause of death in the UnitedStates, according to federal data. The disease, mostly caused bycigarette smoking, can lead to coughing, wheezing, shortness ofbreath and tightness in the chest.
Novartis AG, AstraZeneca Plc andBoehringer Ingelheim have drugs to treat COPD, but Glaxo'sAdvair, with sales of about $8 billion a year, is the marketleader.
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