AstraZeneca PLC Suffers Another Blow After Blood-Thinning Drug Flunks Trial
October 4, 2016
By Alex Keown, BioSpace.com Breaking News Staff
LONDON – AstraZeneca suffered another setback this week as its blood thinning drug Brilinta failed to meet expectations in a large expanded use trial. The drug did not demonstrate a benefit over blood thinner clopidogrel in a symptomatic peripheral artery disease (PAD), the company said this morning.
The trial pitting Brilinta against clopidogrel, which may be better known as Plavix, included nearly 14,000 patients who were 50 years of age or older in 28 countries—making it the largest cardiovascular outcomes trial for patients with PAD, AstraZeneca said. The trial used different doses of the drug to prevent atherothrombotic events—cardiovascular death, heart attack or ischemic stroke. Brilinta is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines
PAD is the third most common cause of cardiovascular complications (largely myocardial infarction and stroke) in the world. PAD is a chronic and progressive clinical manifestation of a systemic atherosclerotic vascular disease and a predictor of future vascular events.
This marks the second setback for Brilinta this year. In March, the company announced the drug failed to meet expectations compared to aspirin in preventing patients from experiencing a second stroke. An ischemic stroke occurs as a result of an obstruction within a blood vessel supplying blood to the brain and accounts for about 87 percent of all strokes, according to the American Stroke Association.
In 2011, the U.S. Food and Drug Administration (FDA) approved the blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes. Brilinta has been seen as a critical component in AstraZeneca’s goal to hit $40 billion in revenue by 2023. Brilinta had been expected the expanded use of the drug to generate more than $3 billion annually for the company. Brilinta had sales of $476 million in 2014.
“The proven benefits of Brilinta in acute coronary syndrome and post-myocardial infarction patients are established and remain unchanged. We are disappointed that the EUCLID trial results showed Brilinta did not demonstrate a benefit over clopidogrel in this specific symptomatic PAD population,” Sean Bohen, AstraZeneca’s chief medical officer, said in a statement.
Based on preliminary analyses, safety data is consistent with the known safety profile of Brilinta, the London-based company said in a statement.
AstraZeneca said it plans to present full results from the EUCLID trial at the American Heart Association Scientific Sessions in New Orleans next month.
Shares of AstraZeneca are down slightly this morning, trading at $32.68 per share.