Bayer’s CV drug, Xarelto Hits Primary Endpoint Early
Bayer has put the blood-thinning drug through its paces in the Phase 3 trial to determine if it could help patients at risk from heart attacks and strokes due to a type of artery disease. The trial was scheduled to end by 2018, however it has proven to be so successful that Bayer could end the trial early, and those on aspirin, as a control group, were then advised to begin taking Xarelto.
Although exact data from the trial has not been released yet, the 27,402-patient trial was revealed to have hit its primary endpoint a full year ahead than predicted. The trial was subject to planned interim analysis by the Independent Data Monitoring Committee which recommended the trial finish early.
The trial featured patients randomised to take either 2.5mg of Xarelto twice daily alongside 100mg of aspirin once daily, 5mg of Xarelto twice daily or 100mg once daily. The full data is expected to be released later this year in a medical meeting.
“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, 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.”
As mentioned, the drug looks very likely to be made available to patients suffering from coronary artery disease and peripheral artery disease. If the drug is given approval, this could see the medication be eligible to a further 30 million patients, on top of the current 25 million patients it aids in the treatment of atrial fibrillation.
The drug is being developed alongside Janssen and will continue with an open-label extension trial to continue to provide Xarelto to patients of the trial.