Xarelto meets phase III endpoint
Berlin – Bayer Healthcare’s oral factor Xa blocker Xarelto (rivaroxaban) has met the primary endpoint of noninferiority to warfarin in a Phase III safety study involving 1,280 Japanese patients, half of whom suffered from attrial fibrillation (AF). Around 800,000 Japanese have been diagnosed with the condition. Besides improved safety, the company also intends to demonstrate prevention of stroke and embolism in patients with these indications, and submitted an MAA in April to Japanese and EU regulatory authorities. At a dose of 15mg once daily, the bloodthinner reduced the risk of embolism by 51% compared to warfarin, even though the study wasn’t designed at statistically demonstrating efficacy, according to Bayer.