ROCKET AF: Positive Results For Xarelto, But A Few Chinks In The Armor
This article was originally published in The Pink Sheet Daily
Rivaroxaban misses two bleeding safety measures, and debate heats up on whether it showed superior efficacy against warfarin.
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TOKYO - Bayer AG's anticoagulant Xarelto (rivaroxaban) met its primary endpoint of clinically relevant bleeding - major and non-major bleeding - in a Japanese Phase III trial, in line with the drug's performance in a 14,000+ global Phase III study, easing the path for approval in Japan
TOKYO - Daiichi Sankyo's R&D leaders are optimistic about how factor Xa inhibitor edoxaban can compete in a potentially crowded market, but the company is also shifting its focus to development of first-in-class compounds, citing commercial and regulatory hurdles for follow-on, best-in-class products
Because regulators and the market have become less accepting of follow-on compounds, the Japanese pharma plans to invest in first-in-class science, pursuing best-in-class opportunities only when it sees a substantial unmet medical need.