AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Priority Review for Reducing Stroke in Patients with Acute Ischemic Stroke or Transient Ischemic Attack

 AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Priority Review for Reducing Stroke in Patients with Acute Ischemic Stroke or Transient Ischemic Attack

AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Priority Review for Reducing Stroke in Patients with Acute Ischemic Stroke or Transient Ischemic Attack

Shots:

  • The US FDA has accepted sNDA and granted PR for Brilinta to reduce subsequent stroke in patients experiencing an acute ischemic stroke or TIA. The sNDA is based on P-III THALES study assessing Brilinta (90mg, bid, for 30 days) + aspirin vs aspirin as monothx. in 11,000 patients with non-cardioembolic acute ischaemic stroke or high-risk TIA
  • The study resulted in a reduction in the risk of the primary composite endpoint of stroke and death while the safety is consistent with the known profile of the therapy. The anticipated PDUFA date is in Q4’20
  • Brilinta (ticagrelor) is an oral, reversible, direct-acting P2Y12 receptor antagonist acts by inhibiting platelet activation. The therapy when co-administered with aspirin prevents atherothrombotic events in adult patients with ACS, or for patients with a history of MI and a high risk of developing an atherothrombotic event

Click here to read full press release/ article | Ref: AstraZeneca | Image: New York Post

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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