- AstraZeneca's heart drug Brilinta missed its primary endpoint in a major global stroke study, failing to demonstrate higher efficacy than aspirin in preventing recurrent attacks after a patient first suffers a stroke.
- Brilinta is an important part of AstraZeneca's growth plan and the study was aimed at expanding use of the drug.
- While fewer events were observed among patients being treated with Brilinta than those taking aspirin, the lower rate was not statistically significant.
Global sales of Brilinta jumped 30% last year compared to 2014, reaching $619 million. In the second half of the year, the FDA had approved a new 60 mg dose for patients with a history of heart attack, helping to boost the drug in the U.S. market.
But the trail failure of the drug compared to aspirin delivers a significant setback to AstraZeneca's hopes for the drug. According to Reuters, the drugmaker has projected Brilinta sales of $3.5 billion by 2023. These results may lead to a lower ceiling for the drug than previously thought.
However, the data from the trial did show a consistent safety profile to what is already known of the drug's effects.
Full trial results are still to come: "“We will present the full analysis of the trial results, including subgroups, at a forthcoming stroke congress and will engage with regulatory agencies on the interpretation of the data," said Sean Bohen, chief medical officer at AstraZeneca.