FDA Denies J&J’s Ask for Extended Approval on Xarelto

Published on March 12, 2015 by Sandy Liebhard

Johnson & Johnson’s attempts to expand uses for Xarelto have been rejected by federal regulators who cite missing data from studies that were supposed to prove its effectiveness, according to Forbes.com.

The U.S. Food and Drug Administration (FDA) announced on February 14th its decision to deny the anticoagulant’s clearance in treating patients with acute coronary syndrome. The drug is right now cleared for people with atrial fibrillation, who may be at risk for serious cardiovascular problems, including pulmonary embolism and deep vein thrombosis, as well as individuals who have recently undergone a hip or joint surgery. According to Forbes, the approval extension for Xarelto was rejected because of holes in Johnson & Johnson’s ATLAS ACS 2-TIMI 51 trial that fail to prove its ability to reduce the risk for MI, stroke and death in acute coronary syndrome patients. The FDA’s decision comes a month after the agency’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously in January to deny Xarelto’s approval for this use. The panel concluded at this time that data included in the study was not enough to prove it to be safe and effective.

But Johnson & Johnson is not planning to give up on seeking Xarelto’s approval for this use. An executive for the company spoke on its behalf recently, and underlined its commitment “to providing patients who have suffered from acute coronary syndrome with additional protection against stent thrombosis and secondary life-threatening cardiovascular events.” The Johnson & Johnson official goes on to note its continued efforts in garnering the drug’s approval for ACS.

More than 220 Xarelto Lawsuits Now Filed in Federal MDL

What Johnson & Johnson fails to mention is the hundreds of Xarelto lawsuits that have been filed in the U.S. Plaintiffs in these cases similarly allege internal bleeding and other complications that are serious, and potentially fatal. These cases have largely been centralized in a federal multidistrict litigation (MDL) now underway in the U.S. District Court, Eastern District of Louisiana. Two months after its creation in December 2015, court documents from February reflect the filing of at least 220 Xarelto lawsuits in the federal proceeding.

Xarelto belongs to a class of new-generation anticoagulants that are together referred to as direct thrombin inhibitors. Approved in 2011, the medication is jointly manufactured by Johnson & Johnson and Bayer Healthcare.

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