Xarelto Studies Designed to Expand Market

Sep 04

Despite thrice being rejected by the Food and Drug Administration (FDA), Johnson & Johnson and Bayer AG are pushing through with clinical trials to make a renewed bid to get approval for its anticoagulant product Xarelto (rivaroxaban) for acute coronary syndrome (ACS). The drug is already approved for ACS treatment in 40 countries outside the US, but the FDA is proceeding with caution with this one.

Perhaps this is because there is a rising tide of discontent against the drug with American patients; the first lawsuits have already been filed claiming that it posed unacceptable levels of danger to patients for its approved uses, primarily for management of atrial fibrillation, deep vein thrombosis, and clot prevention following hip or knee replacement surgery. According to the website of law firm Williams Kherkher, however, the exclusion of ACS as an approved condition for prescription is not limited to Xarelto but for all drugs in the same class, namely direct factor Xa inhibitors or xabans. This could partly be due to the fact that there is no approved reversal agent for this class of drug in case of serious adverse effects, such as uncontrollable bleeding.

The latest attempt by J&J and Bayer to get approval for ACS in March 2014 ran into trouble when the clinical trials presented to the FDA contained inconsistencies in the data that failed to clarify the extent of the benefits and risks of the drug, and the application was denied. Undaunted, J&J and Bayer came up with a different clinical trial design using one antiplatelet drug in conjunction with Xarelto instead of two which is thought will reduce the risk of blooding and will hopefully pass muster in the future. Aside from ACS, the two companies are also hoping to get approval for Xarelto for stroke and peripheral artery disease.

If the FDA issues approval for all pending applications for Xarelto, this would bring the total of all approved conditions for prescription for the drug to 12. That is a potentially huge market; Xarelto is already outpacing its competition for its approved uses. Whether it gets approved for more conditions, Xarelto is already taking a significant slice of the market. Not surprisingly, there are also a growing number of lawsuits being filed against the two companies because of the serious harm the drug has inflicted on some patients. If you have been seriously harmed from using Xarelto, consult with a Xarelto lawyer at once to find out what can be done to compensate you for your medical expenses and losses.

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