Back in the fall of 2012, its sights set on building a blockbuster flagship drug out of its anticoagulant Xarelto, Bayer and its partners at J&J set out to do a massive study to see if the drug could help prevent major cardiovascular events like stroke, myocardial infarction and death in high risk patients with coronary artery disease or peripheral artery disease.
Today, a little more than 4 years and 27,000-plus patients later, investigators say that they hit the primary endpoint well ahead of schedule. Now they’re ending the trial early and launching an extension study where they will continue to dose patients.
Patients were randomized to receive either rivaroxaban 2.5 mg twice daily in addition to aspirin 100 mg once daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg once daily alone.
There’s no data yet, but the company says that the huge study delivered “overwhelming” evidence of the drug’s efficacy.
“Despite established and effective treatments, an unmet medical need in this patient population still exists with rates of CAD and PAD rising globally,” said Dr. Joerg Moeller, a member of the executive committee of Bayer AG’s Pharmaceutical Division and Head of Development. “Bayer is committed to an ongoing clinical development programme that addresses such unmet medical needs. We are excited about these results and look forward to making rivaroxaban available to patients with CAD and PAD to reduce their risk of major adverse cardiac events.”
This is the latest of two big cardio outcomes studies to conclude with a happy ending this month. Amgen reported that its PCSK9 player Repatha also hit its goal in a big study dubbed FOURIER with 27,500 patients. Regulators demand big studies for drugs aimed at major markets like cardio.
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