AstraZeneca plc AZN was saved from heartache after its heart disease drug Brilinta succeeded in a late-stage study, sending its shares higher Monday.
What Happened
AstraZeneca said the Phase 3 study dubbed THEMIS that evaluated Brilinta along with aspirin in patients with coronary artery disease, Type 2 diabetes and no prior heart attack or stroke showed a statistically significant reduction in a composite of major adverse cardiovascular events compared to aspirin alone.
Brilinta is an oral, reversible, direct-acting P2Y12 receptor antagonist that inhibits platelet activation, thereby preventing clots.
The THEMIS study is a multinational, randomized and double-blinded trial initiated in 2014 that evaluated 19,000 patients to collect 1,385 independently adjudicated primary endpoint events.
Why It's Important
The safety data was consistent with the known profile of Brilinta, AstraZeneca said.
"Approaches to help reduce cardiovascular morbidity further in patients with coronary artery disease and Type 2 diabetes are urgently needed. The positive result from the THEMIS trial may offer a potential benefit for this high-risk patient population," Elisabeth Björk, head of late cardiovascular, renal and metabolism in biopharmaceutical R&D, said in a statement.
Brilinta was approved by the U.S. FDA in July 2011 to reduce cardiovascular death and heart attack in patients with acute coronary syndromes. In 2015, it was approved for long-term use in patients with a history of heart attacks.
What's Next
AstraZeneca said a full evaluation of the THEMIS data will be presented at a forthcoming medical meeting.
At last check Monday, AstraZeneca shares were trading up 1.51 percent at $41.56.
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