FDA Spurns Xarelto Approval Agent, For Now
The U.S. Food & Drug Administration (FDA) has declined to approval a medication intended to reverse internal bleeding associated with Xarelto and other new-generation anticoagulants. According to a recent announcement from Portola Pharmaceuticals, the agency says it needs additional information before the medication, known as AndexXa (andexanet alfa), can be cleared for use.
AndexXa is intended to reverse the anticoagulant effects Factor Xa inhibitors, a class of blood thinning medications that incudes Xarelto and Eliquis. As is the case with all blood thinners, these drugs can sometimes cause life-threatening internal bleeding. Though Eliquis and Xarelto have been marketed as improvements over warfarin, there currently exists no approved antidote to reverse their anticoagulant effects should life-threatening hemorrhaging occur. However, internal bleeding associated with decades-old warfarin can be reversed via the administration of vitamin K.
Earlier the FDA had designated AndexXa a breakthrough therapy, which allows for fast-track approval. However, in a Complete Response Letter issued to Portola Pharmaceuticals earlier this month, the agency asked the company to provide more information related to manufacturing of the agent, as well as more data pertaining to the inclusion of Savaysa and enoxaparin in the label. Finally, the FDA indicated that it wanted to finalize a review of the clinical amendments related to the company’s post-marketing commitments.
“Because AndexXa addresses an urgent unmet medical need, we and the FDA are committed to resolving the outstanding questions and determining appropriate next steps,” Bill Lis, Portola’s chief executive officer, in a statement dated August 18th. “Portola’s goal is to define the most expedient path to approval so we can meet the needs of these patients who have no alternative. We plan to meet with the FDA as soon as possible.”
Xarelto Bleeding Litigation
News of the FDA’s rejection comes as more than 7,000 Xarelto lawsuits move forward in a federal multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana. All of the cases pending in the proceeding were filed on behalf of patients who allegedly suffered dangerous episodes of Xarelto bleeding and related complications. Plaintiffs claim that that the drug’s manufacturers failed to provide adequate warnings about its risks, especially the lack of a reversal agent for internal bleeding.
Bernstein Liebhard LLP continues to offer free legal reviews to individuals who may have been harmed by Xarelto. To learn more, please call 877-779-1414 to schedule a free, no-obligation case review.