Bayer’s cardiovascular drug races to target in trial

pharmafile | February 9, 2017 | News story | Research and Development, Sales and Marketing Bayer, Janssen, Xarelto 

Bayer has been putting its blood-thinning drug, Xarelto, through its paces in a Phase 3 trial to determine whether it could help patients at risk from heart attacks and strokes due to a type of artery disease. The trial was expected to end by 2018 but proved so successful that not only was it possible to end the trial early, those on the aspirin, as a control group, were recommended to begin taking Xarelto.

Though exact data from the trial has not been released, the 27,402 patient trial was revealed to have hit its primary endpoint a full year prior than expected. The trial was subject to planned interim analysis by the Independent Data Monitoring Committee which recommended the trial finish early.

The trial saw 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 in 2017 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 by Moeller, the drug looks very likely to be made available to patients suffering from coronary artery disease (CAD) and peripheral artery disease (PAD). 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.

Ben Hargreaves

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