FDA Delays Xarelto Bleeding Remedy a Second Time

Published on January 4, 2018 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) has once again delayed approval for a drug that could reverse uncontrollable bleeding sometimes caused by Xarelto and Eliquis.

Data Request Pushes Xarelto Reversal Agent Approval to May 2018

The manufacturers of the two new-generation blood thinners were hoping that the agency would approve AndexXa, a universal bleeding reversal agent being developed by Portola Pharmaceuticals, early this year. But the agency recently requested additional data from the developer, pushing back any approval to the spring.

“The company recently submitted additional data requested by the agency for the ongoing ANNEXA-4 study as part of the continuing review process, which constitutes an amendment to the submission,” Portola said in a news release dated December 22nd. “Therefore, the agency has instituted an extension to allow more time for a thorough review of the information provided and to work with the company on labeling and post-marketing commitments.  In correspondence dated and issued today, the FDA communicated that the action date will move from February 3, 2018 to May 4, 2018.”

Portola had initially sought to obtain FDA approval for AndexXa by August 2016. But that date was pushed back when the agency sought additional information on the company’s manufacturing as well as more data for inclusion of two other blood thinners in the label, Savaysa and Lovenox.

Currently No Approved Remedy for Xarelto Bleeding Events

Xarelto is marketed jointly by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary. The blood thinner was initially approved by the FDA in October 2011 and is currently indicated to treat:

  • Prevention of stroke in patients with non-valvular atrial fibrillation.
  • Treatment of deep vein thrombosis and pulmonary embolism.
  • To reduce the risk of recurrent deep vein thrombosis and pulmonary embolism.
  • To prevent deep vein thrombosis, which may result in pulmonary embolism, in patients undergoing hip or knee replacement surgery.

The drug’s manufacturers recently asked the FDA to expand Xarelto’s approved uses to include:

  • Reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke in patients with chronic coronary and/or peripheral artery disease (CAD/PAD
  • Reducing the risk of acute limb ischemia in patients with PAD

While all blood thinners can cause episodes of uncontrollable bleeding, there currently exists no approved antidote to reverse Xarelto bleeding side effects.

Xarelto Bleeding Litigation

Court documents indicate that more than 20,000 Xarelto lawsuits are currently pending in courts around the U.S.

Plaintiffs who have filed these cases claim that the Bayer and Janssen understated the risks associated with the medication and wrongly marketed it as an improvement to warfarin, a decade’s old medication sold under the brand name Coumadin. Among other things, they point out that internal bleeding associated warfarin can be stopped via the administration of vitamin K.

On December 4th, a jury in the Philadelphia Court of Common Pleas awarded $28 million ($1.8 million in actual damages and $26 million in punitive damages) to an Indiana woman who developed gastrointestinal bleeding after taking Xarelto for a little over a year.

The majority of Xarelto lawsuits are pending in a federal multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana. So far three cases have gone to trial in that proceeding, all of which concluded with defense verdicts.

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