FDA Approves Pradaxa for Stroke Risk Reduction in Non-Valvular Atrial Fibrillation

Strategic Insights -

The US Food and Drug Administration (FDA) has approved Pradaxa (dabigatran etexilate), a novel oral direct thrombin inhibitor, for the reduction of stroke risk in patients with non-valvular atrial fibrillation (AF). This approval marks the first new oral anticoagulant to be approved in the US in over 50 years. Pradaxa's approval is based on findings from the RE-LY trial, which demonstrated a significant reduction in stroke and systemic embolism risk, as well as a reduction in life-threatening and intracranial bleeding.

Key Takeaways:

  • The FDA has approved Pradaxa for stroke risk reduction in patients with non-valvular atrial fibrillation (AF), making it the first new oral anticoagulant approved in the US in over 50 years.
  • The approval is based on findings from the RE-LY trial, which demonstrated a 35% reduction in stroke and systemic embolism risk compared to warfarin.
  • Pradaxa's 150mg bid dose is approved for all patients except those with severe renal impairment (creatinine clearance 15-30 mL/min), who are approved for the 75mg bid dose.
  • Pradaxa does not require monitoring or dose adjustments, and is not affected by food or many common co-medications.
  • The RE-LY trial showed significant reductions in major bleeding events and life-threatening and intracranial bleeding with both doses of Pradaxa.
  • AF is the most common heart rhythm condition, affecting around 1% of the total population, rising to 10% in people over the age of 80.
  • People with AF are at increased risk of blood clots, which raises stroke risk by five times, with up to three million people worldwide suffering strokes related to AF each year.

Statistics:

  • 35% reduction in stroke and systemic embolism risk with Pradaxa 150mg bid compared to warfarin (RE-LY trial).
  • 50% of eligible patients do not receive VKA therapy due to drug-drug and food interactions, as well as the requirement for frequent monitoring (Source: Boehringer Ingelheim).
  • 1% of the total population is affected by AF, rising to 10% in people over the age of 80.
  • Up to three million people worldwide suffer strokes related to AF each year.

Sources:

  • Business Wire (2010-10-20)
  • Boehringer Ingelheim (www.boehringer-ingelheim.com/news/news_releases/press_releases/2010_20_october_2010_dabigatran.html)