The safety profile for Brilinta was consistent with the known profile of the medicine with an increased risk of bleeding events observed in both THEMIS and the THEMIS-PCI sub-analysis.
AstraZeneca announced detailed results from the positive Phase III THEMIS trial, which showed BRILINTA plus aspirin reduced the relative risk for the composite of cardiovascular death, heart attack, or stroke by 10% compared with aspirin alone, a statistically significant reduction.
With Brilinta, the THEMIS trial demonstrated the potential of this medicine in patients with coronary artery disease and diabetes who are at high-risk of having a cardiovascular event.'
AstraZeneca was also boosted by strong growth for heart disease drug Brilinta and diabetes medicine Farxiga, with all five drugs expected to reach annual sales of at least $1bn (PS800m).
In conjunction with the approval, the A-100 ADP cartridge was evaluated for clearance in several clinical sites in the US using US FDA-approved combinations of dual anti-platelet therapies (Plavix, Brilinta and Effient).
It's possible that another P2Y12 inhibitor, such as ticagrelor (Brilinta), might work even better, but that needs to be proven to justify the added expense of a brand-name antiplatelet drug.
The study's design gave each participating clinician free rein on whether to prescribe clopidogrel or ticagrelor (Brilinta) initially, and switching between the drugs was possible at any time after the initial prescription.
The UAE Ministry of Health and Prevention has issued a circular to all medical facilities and hospitals to withdraw Brilinta 90 mg batch number JB504 by AstraZeneca, with immediate effect because of wrong packaging.