NICE gives limited approval for prasugrel

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The National Institute for Health and Clinical Excellence (NICE) has issued approval for the marketing of prasugrel (Efient in EU/Effient in U.S.) from Eli Lilly and Daiichi Sankyo, with a few limitations.

According to NICE, prasugrel in combination with aspirin is now recommended as an option for preventing atherothrombotic events in people with acute coronary syndromes (ACS) having PCI, only when:

  • immediate primary PCI for STEMI is necessary; or
  • stent thrombosis has occurred during clopidogrel (Plavix from Bristol-Myers Squibb) treatment; or
  • the patient has diabetes mellitus.

However, the agency said that patients currently receiving prasugrel for treatment of ACS whose circumstances do not meet these criteria “should have the option to continue therapy until they and their clinicians consider it appropriate to stop.”