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Heart Attack Signal Is Likely Focus For Panel Review Of Boehringer Ingelheim's Pradaxa

This article was originally published in The Pink Sheet Daily

Executive Summary

When FDA's Cardiovascular and Renal Drugs Advisory Committee meets Sept. 20 to consider Boehringer Ingelheim's Pradaxa (dabigatran) for stroke prevention, a significantly higher rate of heart attacks among clinical trial patients compared with warfarin is likely to come up.

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Bayer/J&J’s factor Xa inhibitor Xarelto (rivaroxaban) met its endpoints in the head-to-head ROCKET AF study against warfarin, but on some major bleeding outcomes measures it actually did worse than warfarin, and the effects of the widely used generic appear to have been sub-par in the 14,000-patient study.

ROCKET AF Yields Positive Results For Xarelto, But A Few Chinks In The Armor

Bayer/J&J’s factor Xa inhibitor Xarelto (rivaroxaban) met its endpoints in the head-to-head ROCKET AF study against warfarin, but on some major bleeding outcomes measures it actually did worse than warfarin, and the effects of the widely used generic appear to have been sub-par in the 14,000-patient study.

ROCKET AF: Positive Results For Xarelto, But A Few Chinks In The Armor

Rivaroxaban misses two bleeding safety measures, and debate heats up on whether it showed superior efficacy against warfarin.

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