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Glaxo lung drug fails in huge study
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GlaxoSmithKline’s inhaled medicine Breo failed to prolong life in patients with chronic respiratory disease in a high-stakes clinical trial of 16,500 people, torpedoing hopes of a sales boost for the drug.
Shares in Britain’s biggest drugmaker fell 1.5 percent yesterday, lagging a strong London market, in reaction to the news announced by the company and its partner Theravance on Tuesday. Theravance plunged 15 percent.
Investors had hoped the large study would increase sales for the medicine, potentially by billions of dollars, underpinning GSK’s all-important respiratory business in the face of increasing competition.
Breo was approved in 2013 for chronic obstructive pulmonary disease (COPD), a leading cause of death worldwide that is often referred to as smoker’s cough, but sales have been slow to take off.
While Breo did lower the risk of dying by 12.2 percent compared to placebo, the difference was not big enough to be deemed statistically significant.
Had it succeeded, Breo would have been the first drug to show a survival benefit in patients with COPD.
The drug also reduced the rate of decline in lung function and heart problems, but because Breo failed its main study goal, statistical significance could not be inferred for these or other secondary objectives. Serious adverse events were similar on Breo and placebo.
Nine years ago, a similar study with GSK’s older drug Advair, involving 6,100 patients, also narrowly failed.
Inhaled drugs such as Breo that combine a steroid and a long-acting beta agonist help patients breathe more easily but their effect on survival has been unclear.
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