AstraZeneca Says US FDA Approves Expanded Indication For Brilinta

The drug, which is meant to prevent blood clots that can cause heart attacks and strokes, had previously been approved at a higher dose for use during the first year after a heart attack. It could also increase the numbers of patients eligible for the drug to include those who had a heart attack more than a year ago.

According to Antoine Yver, head of oncology in global medicines development at AstraZeneca, “AZD9291 is moving through clinical development with unprecedented speed, and was recently granted United States priority review designation”.

AstraZeneca’s blood-thinner Brilinta can be used as a long-term treatment for some patients, the company said.

In the management of ACS, the recommended maintenance dosage of Brilinta is 90 mg twice daily during the first year after an ACS event. “Today’s approval provides an important new treatment option and underscores the role Brilanta can play in reducing the risk of a subsequent cardiovascular event for patients both in the acute setting and in the longer term”. The approval was based on data from the PEGASUS TIMI-54 study, an outcomes trial involving more than 21,000 patients.

Tom Keith-Roach, vice president for Brilinta at AstraZeneca, told Reuters the FDA endorsement would shift thinking among heart doctors and expand the market, as clinical practice moves increasingly towards longer-term drug use.

The new 60-mg tablet is expected to be available by the end of September 2015. The study was conducted in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group from Brigham and Women’s Hospital (Boston, MA, USA). AstraZeneca is assessing Brilinta for the avoidance of cardiovascular events in patients with ischemic stroke or transient ischemic attack, peripheral arterial disease, diabetes and coronary atherosclerosis.