Texas Xarelto LawyerAugust 19, 2016 — In a surprise move, the FDA has delayed approval of the first-ever medication to stop uncontrolled bleeding in patients on Xarelto and similar blood-thinners.

Portola Pharmaceuticals reported the FDA has requested more information on product manufacturing. The agency also wants more data to support the inclusion of Savaysa and Lovenox on the label.

AndexXa (andexenet alfa) is an FDA-designated “breakthrough” drug that is designed to counteract life-threatening bleeding in patients on direct or indirect Factor Xa inhibitors, which includes:

  • Xarelto (rivaroxaban)
  • Eliquis (apixaban)
  • Savaysa (enoxaban)
  • Lovenox (enoxaparin)

There is currently no FDA-approved reversal agent for Factor Xa inhibitors on the market. Approximately 1-4% of patients on these drugs develop uncontrollable bleeding that requires an antidote.

Portola submitted an approval application after two Phase III clinical trials in which AndexXa performed well against a placebo in healthy volunteers aged 50-75 years old on Xarelto or Eliquis.

The data showed that AndexXa reversed Eliquis by 93.5% and Xarelto by 92%. In both cases, the effects were sustained for two hours.

Bayer and Janssen Pharmaceuticals are facing about 8,000 lawsuits from people who took Xarelto and experienced uncontrolled bleeding. The drug-makers are accused of downplaying the risk of bleeding and aggressively marketing Xarelto as superior to warfarin, a blood-thinner that can easily be reversed with a dose of Vitamin K.

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