AstraZeneca PLC's Brilinta Proves Worthy Despite Higher Bleeding Risk
Published: Mar 16, 2015
March 16, 2015
By Alex Keown, BioSpace.com Breaking News Staff
WILMINGTON, Del. -- Continued clinical studies of AstraZeneca PLC ’s Brilinta show the drug reduces the threat of a recurring heart attack long after patients suffer their initial attack – news the pharmaceutical giant believes will generate billions in annual sales.
The PEGASUS-YIMI 54 clinical trials found the 90mg and 60mg study doses of ticagrelor with aspirin significantly reduced the cardiovascular death, myocardial infarction or stroke compared to placebo. However, the study also confirmed that bleeding risks are higher with both doses of ticagrelor plus aspirin, AstraZeneca reported over the weekend. The rates of fatal bleeding or intracranial hemorrhage were low, however, AstraZeneca said during the American College of Cardiology’s annual meeting in San Diego on Saturday.
People who suffer a heart attack are more likely to experience another heart attack, or other conditions such as stroke, kidney disorders, and peripheral arterial disease, according to the Centers for Disease Control and Prevention (CDC). For patients more than one year from a heart attack, the current standard of care is aspirin alone. The latest trial showed that patients who continue on Brilinta for an average of 33 months following their initial heart attack had a 15 percent reduction in the chance of a secondary heart attack or stroke, the company said.
The PEGASUS- TIMI 54 clinical trial results testing Brilinta and a dosage of aspirin versus a placebo in patients for chronic secondary prevention of artherothrombotic, the hardening and narrowing of the arteries, in patients who suffered a heart attack one to three years before entering the study showed a statistically significant reduction in blood clot-related cardiovascular events compared to the placebo. The PEGASUS trial involved over 21,000 patients.
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. With the latest trial evidence AstaZeneca said the findings have spurred it to pursue regulatory filings to seek approval for additional uses for the medication. AstraZeneca is banking on Brilinta to generate annual sales of $3.5 billion by 2023, based on expanded use for heart attack patients as well as moving into additional disease areas such as stroke and diabetes, according to a Bloomberg Business report report. Brilinta had sales of $476 million in 2014.
In its initial clinical trials before receiving FDA approval, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 milligrams once daily, the FDA said. However, Plavix, which is now sold as the generic Clopidogrel is far less expensive than Brilinta. Clopidogrel costs about $12 a month, compared to about $270 for Brilinta.
In 2011 Brilinta was approved with a Risk Evaluation and Mitigation Strategy, a plan to help ensure that the drug’s benefits outweigh its risks, the FDA said. As part of that plan, the company must conduct educational outreach to physicians to alert them about the risk of using higher doses of aspirin.
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