Brilinta: Phase III data
Top-line data from the double-blind, international Phase III PEGASUS-TIMI 54 trial in >21,000 patients ages ³50 who had experienced a heart attack 1-3 years prior to the start of the study and who had 1 additional cardiovascular risk factor showed that twice-daily 60 and 90 mg oral Brilinta plus low-dose aspirin each met the primary endpoint of reducing a composite of cardiovascular death, non-fatal MI and non-fatal stroke vs. placebo plus low-dose aspirin. AZ said it hopes to present data from the trial at the American College of Cardiology meeting in San Diego in March.
PEGASUS-TIMI 54 is part of the PARTHENON program of Brilinta in nearly 80,000 patients at high risk of cardiovascular events seeking to expand the product’s label. AZ is also conducting 3 other Phase III trials under PARTHENON -- THEMIS to prevent major cardiovascular events in Type II diabetics without a history of previous MI or stroke; EUCLID to reduce major cardiovascular events in patients with peripheral artery disease (PAD); and SOCRATES in patients who have experienced an acute ischemic stroke or transient ischemic stroke. AZ expects data from SOCRATES this year. ...