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By Toni Clarke
April 17 (Reuters) - An advisory panel to the U.S. Food andDrug Administration recommended on Wednesday that the agencyapprove an experimental treatment for smoking-related lungdamage made by Britain's GlaxoSmithKline Plc andTheravance Inc.
Glaxo's U.S.-traded shares rose 1 percent to $49.92immediately following the vote. Theravance's shares remainedhalted shortly after the vote. On Monday, they rose more than 17percent following a favorable initial review of the drug by FDAstaff.
The drug, Breo, is an inhaled treatment for chronicobstructive pulmonary disease (COPD), a condition that includesemphysema, chronic bronchitis or both. COPD is the third-leadingcause of death in the United States, according to federal data.
Breo consists of a corticosteroid, fluticasone furoate,which reduces inflammation, and a novel long-actingbeta-agonist, or LABA, called vilanterol, which is designed toopen the airways. The product is inhaled through a palm-sizeddevice called Ellipta.
Breo, or Relvar as it would be called outside the UnitedStates, would compete with, and potentially ultimately supplant,GSK's twice-daily asthma and COPD drug Advair, a roughly $8billion-a-year drug that contains the steroid fluticasonepropionate and the long-acting beta-agonist salmeterol.
Breo would also compete with AstraZeneca Plc's twice-a-day Symbicort, an inhaled combination of thecorticosteroid budesonide and the long-acting beta-agonistformoterol.
Glaxo and Theravance are hoping the once-daily delivery ofBreo will make their drug more attractive to patients.
The FDA is not obliged to follow the recommendations of itsadvisory panels, but typically does so.
(Reporting By Toni Clarke in Washington; Editing by Gerald E.McCormick and Leslie Adler)
