The makers of Xarelto are seeking to get the blood thinner approved for uses other than the prevention of strokes in atrial fibrillation patients, by way of three new studies that involve the anti-clotting drug.
According to a Yahoo News report on August 29th, a Phase III trial of 7,000 individuals may determine whether the medication is effective in preventing the recurrence of strokes that occurred for reasons unrelated to this condition. Xarelto is currently approved to reduce strokes caused by atrial fibrillation, which Bayer HealthCare says is failing to address other patients who may have suffered this cardiovascular injury. “We really have just as many strokes due to undetermined causes as to atrial fibrillation,” the company’s head of Therapeutic Area Cardiovascular and Coagulation told Yahoo News.
According to the article, Xarelto sales reached $1.7 billion in the 12 months preceding June 2014. Analysts are predicting annual sales growth of the drug to reach more than $9.5 billion by 2020. Meanwhile, court records show an uptick in Xarelto lawsuit filings now pending in various U.S. courts.
Another Phase III trial involves the possible benefits of Xarelto in reducing thrombotic vascular complications in patients with peripheral artery disease, while a third is designed to examine its effectiveness in preventing acute coronary syndrome. Bayer plans to examine between 2,000 and 3,000 patients for this study, which will be followed up with a Phase III trial if the first is successful.
When Xarelto first garnered U.S. Food and Drug Administration (FDA) approval in 2011, the new-generation blood thinner was cleared for use in treating deep vein thrombosis and pulmonary embolism. The medication is also cleared to reduce the risk of blood clots in strokes in patients with an irregular heart-beat not related to heart problems.
Xarelto has also been blamed for uncontrollable internal bleeding injuries allegedly sustained by numerous individuals. According to recent reports, numerous Xarelto lawsuits have been filed by plaintiffs who allege life-threatening side effects of the medication they were inadequately warned about by Bayer and Johnson & Johnson. Xarelto is marketed as an improvement over the decades-old blood thinner, warfarin, which may also cause internal bleeding but can be stopped with the administration of Vitamin K.
Hundreds of Xarelto internal bleeding reports have also been reported to the FDA, the Institute for Safe Medicine Practices reported this summer. In the first quarter of 2013, 680 complaints had been filed by users of the medication, which surpassed those involving Pradaxa.