AstraZeneca's Brilinta (ticagrelor) Receives the US FDA's Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
Shots:
- The approval is based on P-III THALES study involves assessing Brilinta (180mg as a loading dose followed by 90mg- bid) + aspirin vs aspirin as monothx. in 11-000 patients with non-cardioembolic acute ischaemic stroke or high-risk TIA for 30days
- Results demonstrated a reduction in the rate of the composite 1EP of stroke & death by 17%- risk of severe bleeding events (0.5% vs 0.1%). Regulatory submissions to expand the approved indication are under regulatory review in China and the EU
- Brilinta (ticagrelor) is an oral- reversible- direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation. The approval follows the US FDA’s PR designation granted in Jul’2020
Ref: AstraZeneca | Image: Mint
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