AZ unveils Brilinta data, seeks label extension

AstraZeneca plc (LSE:AZN; NYSE:AZN) revealed new details from a 21,000-patient CV outcomes study showing that long-term use of the anticoagulant Brilinta ticagrelor reduced the incidence of major thrombotic cardiovascular (CV) events. AZ has submitted applications to FDA and EMA to expand the drug's label to include long-term use beyond one year, but declined to disclose when it expects decisions from the agencies.

In the three-year PEGASUS-TIMI 54 study, twice-daily dosing with 60 mg or 90 mg of oral Brilinta plus aspirin beat placebo plus aspirin on the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI) and stroke. Three-year event rates were 7.9% in the 90 mg arm, 7.8% in the 60 mg arm and 9% in the placebo arm (p=0.008 for 90 mg, p=0.0043 for 60 mg, both vs. placebo). ...