UK based Pharmaceutical firm GlaxoSmithKline PLC has failed to show that the company’s Breo Ellipta inhaler extends life in patients with chronic obstructive pulmonary disease, dashing hopes of a sales boost for the product. Glaxo had hoped that the so-called Summit study, which tested Breo against a placebo in 16,485 patients from 43 countries, would demonstrate that the product prolonged life as well as helped with breathing.
Summit was the first study to test the effect on survival of inhaler products like Breo, which open up the airways to ease breathing in patients with asthma or COPD. It enrolled patients at higher risk of cardiovascular disease to see if Breo could bring added survival benefits to this group. About half of the people diagnosed with COPD are at heightened risk of cardiovascular disease.
The company said patients on Breo were 12.2% less at risk of dying than those on the placebo, but the difference wasn’t large enough to be significant. The drug also reduced the rate of lung infections and heart problems, but Glaxo said it couldn’t draw any solid conclusions from those secondary studies.
Still, the results are a blow to Glaxo. A positive result could have boosted sales of Breo by encouraging doctors to prescribe the drug over others in patients with higher cardiovascular risk. Breo is one of the drugs Glaxo is betting on to increase sales as its older blockbusters lose patent protection, but the drug’s market share hasn’t grown as quickly as expected because U.S. insurers have been slow to cover the drug.
Breo was launched in the U.S. in 2013 as a treatment for COPD. It later won approval from the Food and Drug Administration for use in adults with asthma. In Europe, where the product is known as Relvar Ellipta, the drug is used for COPD and asthma.
Glaxo has become a lower-margin company following its $20 billion asset swap with Novartis AG, in which it traded its highly profitable oncology franchise for the Swiss company’s vaccines business, which has slimmer margins. The pair also formed a joint venture, controlled by Glaxo, for their over-the-counter medicines, which also have lower margins than prescription pharmaceuticals.
