Scientists for AstraZeneca have pulled the wraps off their head-to-head Phase III trial for the blockbuster clotting drug candidate Brilinta, offering a detailed look at the therapy's improved performance over Plavix for reducing the risk of heart attacks without increasing the risk of bleeding. And several analysts applauded the drug's safety and efficacy profile, noting that Brilinta is well positioned to grab a big chunk of Plavix's $10 billion annual haul.
In the study, patients with acute coronary syndrome taking Brilinta (ticagrelor) were 16 percent less likely to die from cardiovascular symptoms, heart attack or stroke than patients taking Plavix. And remarkably there was a 22 percent drop in the rate of death from all causes. There was also no statistically significant increase in the risk of major bleeding.
The numbers offer solid proof that AstraZeneca is well on its way to gaining an approval for Brilinta, which would compete against Plavix--the second biggest drug by sales in the world--as well as the newly released Effient from Eli Lilly and Daiichi Sankyo, which was approved despite demonstrating an increased risk of bleeding. AstraZeneca plans to file the drug in Europe and the U.S. in the fourth quarter and sales estimates reach up to $2.5 billion a year.
Unlike Plavix, Brilinta is reversible and is not metabolically activated by the liver. "Not everyone's liver has the machinery to convert Plavix to the active metabolite," Dr. Paul Gurbel, a lead researcher in the study, tells FierceBiotech. "Thirty percent possess at least one gene associated with loss of function."
One potential trouble spot: It didn't take long for American Heart Association President Clyde Yancy to note that the North American patient group did not show a favorable result in the trial. "Is that a statistical fluke?" he told Reuters. "Or is that a circumstance where because of contemporary treatment patterns in the U.S. whatever benefit you might have expected to get from this drug is masked within the morass of everything else we do?"