Full Brilinta study results show the blood thinner reduces rate of secondary stroke
AstraZeneca once projected its Brilinta drug to peak at $3.5 billion in sales, and though the blood thinner never reached that lofty goal, it received the latest positive signs in a string of recent good news.
The pharma released full details from its THALES study Thursday morning, which measured the effects of Brilinta and aspirin against aspirin alone in treating patients who had an acute ischemic stroke or transient ischemic attack. When taken twice daily with once-a-day aspirin for 30 days, the Brilinta combo reduced the risk of stroke and death by 17 percent, meeting the primary endpoint of the study.
Additionally, the Brilinta and aspirin combo met the study’s first secondary endpoint — reducing the rate of ischemic stroke by 21 percent compared to aspirin alone. Side effects were also within the combination’s known safety profile, with severe bleeding events occurring in 0.5 percent of patients in the trial arm compared to 0.1 percent in the control.
About one in four stroke survivors experience a second stroke, according to THALES lead investigator Clay Johnston, with a higher risk of recurrence within the first month.
Just last week, the FDA accepted the sNDA for Brilinta and granted it a priority review for this treatment area. And in May, US regulators approved a label update for Brilinta to include the risk reduction of a first heart attack or stroke in high-risk patients with coronary artery disease.
The agency will decide whether or not to accept the sNDA sometime in the fourth quarter of 2020.
In 2019, Brilinta netted AstraZeneca over $1.5 billion, including more than $400 million each in the third and fourth quarters.
Brilinta has faced a long and winding road following AstraZeneca’s initial $3.5 billion forecast, flopping in two big trials in 2016. The drug failed to show any difference from aspirin in treating acute ischemic stroke or transient ischemic attack or from Plavix for peripheral artery disease.
Fortunes rebounded in 2017 when the drug illustrated a reduction in CV death in patients who had previously suffered a heart attack, and again in 2019 when the Brilinta-aspirin cocktail reduced major adverse CV events in diabetics with no prior heart attack or stroke. The latter study, however, was accompanied with a significantly higher risk of major bleeding events.