Rivaroxaban "superieur" vs warfarine bij strokereductie

Bayer, Johnson & Johnson's Xarelto shows "superiority" in stroke reduction over warfarin

November 15, 2010

Press release ROCKET-AF study.
Slides ROCKET-AF study.

Bayer and Johnson & Johnson announced Monday that results of a late-stage trial of once-daily Xarelto (rivaroxaban) demonstrated "superiority" compared to warfarin in reducing the risk of stroke and systemic embolism in patients with atrial fibrillation.

The results of the ROCKET AF trial, which were presented at the American Heart Association meeting, also demonstrated that patients who took Xarelto had "comparable major and non-major clinically relevant bleeding" compared to warfarin.
 

Earlier in the month, the companies reported that the study met its primary goal of demonstrating that the drug was comparable in efficacy to warfarin. Peter DiBattiste, vice president of cardiovascular development at Johnson & Johnson, noted that the new data "show pretty convincingly that we have a real alternative here that is effective, that’s better than warfarin, that’s easy to manage and is once daily," adding that the dug doesn't "have any safety signal[s] of concern."
 

The trial randomised 14 264 patients with non-valvular atrial fibrillation at risk of stroke and systemic embolism to receive once-daily Xarelto or dose-adjusted warfarin. Data showed that patients who took Xarelto were 21-percent less likely to suffer a stroke or embolism than those on warfarin. Frank Misselwitz, head of Bayer's cardiovascular unit, said "the trial exceeded expectations," adding that the results don’t put Xarelto at a disadvantage compared with Boehringer Ingelheim's recently approved Pradaxa (dabigatran etexilate). In a clinical trial, the drug, which is taken twice daily, reduced the risk of stroke by 34 percent without increasing the risk of bleeding.
 

In the ROCKET AF study, Bayer and Johnson & Johnson noted that the rate of major bleeding was 3.6 percent for patients receiving Xarelto, compared to 3.5 percent for those taking warfarin. Furthermore, patients taking Xarelto were about one-third less likely to develop intracranial bleeding, and experienced approximately one third fewer critical organ bleeds and half the risk of fatal bleeding. In addition, an estimated 41- percent reduction in the risk of haemorrhagic stroke was observed.
 

Johnson & Johnson plans to file for US regulatory approval of Xarelto before the end of the year, and Misselwitz indicated Bayer plans to do the same in Europe. Misselwitz confirmed earlier "conservative" sales estimates for the drug, with the company predicting it could generate annual revenue exceeding 2 billion euros ($2.7 billion) a year, in a market that could surpass $14 billion annually.
 

Sanford C. Bernstein analysts estimate that Xarelto could achieve combined peak sales for Bayer and Johnson & Johnson of $3.9 billion by 2020 if the drug is as effective as Pradaxa. "The big advantage Pradaxa has is the data looks very good, everyone has been poring over it for ages, and it’s now on the market without a competitor," analyst Alex Blanckley said.