BRILIQUE 60 mg (ticagrelor), platelet aggregation inhibiting drug

CARDIOLOGY - New medicinal product
Opinions on drugs - Posted on Aug 28 2017

Reason for request

Inclusion

Insufficient actual benefit in secondary prevention beyond one year after myocardial infarction

  

  • BRILIQUE 60 mg has Marketing Authorisation, in combination with acetylsalicylic acid (ASA), in the prevention of atherothrombotic events in adult patients with a history of myocardial infarction (MI) and at high risk of developing an atherothrombotic event. 
  • BRILIQUE 90 mg, which is already available, has Marketing Authorisation in secondary prevention for the first 12 months following acute coronary syndrome. This new dosage of 60 mg has Marketing Authorisation only for long-term treatment beyond one yearof patients with a history of MI and at high risk of developing an atherothrombotic event.
  • The long-term combination of BRILIQUE 60 mg with aspirin, beyond one year after an MI, has shown a modest gain in terms of efficacy, at the expense of an increase in bleeding risk and dyspnoea. The net clinical benefit in favour of this strategy has not been demonstrated.

 


Clinical Benefit

Insufficient

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