A secondary endpoint of reducing the risk of experiencing a CV event while on treatment also failed to achieve statistical significance (p=0.475) despite an observed reduction of 7.4% versus placebo.
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“While the study was unable to demonstrate a statistically significant improvement on this endpoint, it provides us with a wealth of data to help us as clinicians understand the interplay between these two conditions and insights on how to improve the management of these patients”, said lead investigator, Jørgen Vestbo, Professor of Respiratory Medicine at the Centre for Respiratory Medicine and Allergy, University Hospital South Manchester NHS Foundation Trust and the University of Manchester. Shares of far-larger Glaxo rose 2.2 per cent in New York, lagging a 2.5 per cent gain for the broader stock market. It also includes chronic bronchitis and emphysema. Longtime blockbuster Advair has seen sales tumble as multiple brand-name rivals have forced price cuts, compounded by generic competition in several foreign countries. Anderson predicts that competition will hit in the U.S.in 2017.
Current consensus forecasts point to Breo sales of US$1.55 billion by 2020, according to Thomson Reuters Cortellis. Worldwide Advair sales fell 14% to $2.9 billion during the same time. With the failure, hopes of the company regarding the product have shattered. Breo Ellipta is one of the four new drugs in the category that GSK has won approval for in recent years, but sales of all four have been disappointing till now. The company enrolled patients who were at higher risk of cardiovascular disease in order to observe that if Breo is capable of bringing additional survival benefits to them.
It was the first study that tested the impact on survival of inhaler products such as Breo that open up the airways so as to make breathing easy in patients suffering from asthma or COPD.
Nine years ago, a very similar study with GSK’s older drug Advair, involving 6,100 patients, also narrowly failed.
Sanford Bernstein analyst Dr. Tim Anderson noted that unlike Glaxo’s earlier study of Advair, called TORCH, SUMMIT had better odds of succeeding because it focused on cardiac patients with increased risk of death.
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Sometimes known as “son of Advair”, once-a-day Breo has a dosing advantage over twice-daily Advair.
