Just Days After $28 Million Xarelto Lawsuit Verdict, Janssen Seeks Expanded Indications from FDA

Published on December 12, 2017 by Sandy Liebhard

Just a week after a Pennsylvania jury awarded nearly $28 million to a woman who suffered serious gastrointestinal bleeding while taking Xarelto, the drug’s makers asked federal regulators to approve the blood thinner for two new indications.

According to a press release issued on December 11th, Janssen Research & Development, LLC filed a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA), asking that Xarelto’s approved indications be expanded 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

If the application is approved, Xarelto would become the only Factor Xa inhibitor indicated for these patient groups.

Xarelto Current Indications

Xarelto was developed by Bayer, which jointly markets the drug with Johnson & Johnson’s Janssen subsidiary. The new-generation blood thinner was initially approved by the FDA in October 2011, and is currently approved for:

  • 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.

Xarelto Bleeding Litigation

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

While all blood thinners can cause internal bleeding, plaintiffs who have filed Xarelto lawsuits claim that the drug’s manufacturers understated the risks associated with the medication and wrongly marketed it as an improved to warfarin. Among other things, they point out that internal bleeding associated with the much-older drug can be stopped via the administration of vitamin K. There is currently no approved antidote to reverse bleeding that may occur in Xarelto patients.

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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