- GlaxoSmithKline/Theravance's Breo Ellipta (Breo), which combines fluticasone and vilanterol, was approved for the treatment of chronic obstructive pulmonary disease (COPD) in 2013. It is also used to treat asthma. As of April 2015, Breo is now approved for treatment of asthma in adults.
- In a massive 16,500-person clinical trial, although Breo lowered the risk of dying by 12.2%, the results were not statistically significant (P=0.137). That means the drug did not meet its primary endpoint in the study, delivering Glaxo and Theravance a body blow for their next-gen respiratory ambitions.
- Breo performed very well with respect to secondary measures. It not only reduced the rate of decline in lung function, compared with placebo, but it also reduced the risk of having a heart attack, stroke, or other cardiovascular (CVD) event by 7.4%. However, these secondary measures were deemed ultimately inconclusive due to the drug's failure to meet the primary endpoint.
By many accounts, Breo is an effective drug; however, GlaxoSmithKline (GSK) and Theravance were hoping that Breo would do something no other COPD drug has been able to do in clinical trials—show a survival benefit in patients with COPD.
GSK also makes the flagship Advair, an older treatment for COPD, which is considered a predecessor product to Breo. The challenge for the GSK/Theravance Breo team has been attempting to generate more uptake of Breo when Advair is widely used and broadly accepted. Moreover, physicians generally do not heavily differentiate between Advair and Breo, and Breo sales have not exactly been impressive to date.
Although researchers did not meet primary endpoints, the fact that COPD-related therapeutics is being studied and advanced is important, especially considering the fact that COPD is the third leading cause of death in America.
Theravance's stock plunged on the news on Tuesday and continued to plummet on Wednesday morning (down more than 9% in early trading). Glaxo, as a far larger company, has not seen a big decline in its share price on the results were released.