FDA Rejects Xarelto Bleeding Antidote
Portola Pharmaceuticals was dealt a blow when its breakthrough drug AndexXa was turned down by health regulators earlier this month. The U.S. Food and Drug Administration (FDA) says it needs more information before approving a new antidote for life-threatening bleeding linked to blood thinners like Xarelto and Eliquis.
AndexXa (andexanet alfa) was a first-in-class medication designed to reverse uncontrollable bleeds in patients taking direct or indirect Factor Xa inhibitors, including: apixaban, rivaroxaban, edoxaban and enoxaparin. AndexXa, an FDA-labeled Breakthrough Therapy, was fast-tracked for review and approval to address a mounting number of life-threatening bleeding events associated with blood thinners.
Despite promising results in early AndexXa trials, the FDA rejected the drug, and sent Portola a “Complete Response Letter.” The letter, sent on August 16, asks for additional data on manufacturing processes that may help facilitate inclusion of enoxaparin and edoxaban on AndexXa drug labels. The agency also needs more time to further evaluate the drug manufacturer’s post-marketing strategies.
Possible Xarelto antidote rejected by FDA
Portola’s pre-market studies included the ANNEXA-A trial, which demonstrated the superior anticoagulant effects of AndexXa in patients taking Eliquis. According to the results, the drug rapidly reversed uncontrolled bleeds by 93.5 percent within a span of two hours.
After AndexXa’s drug application was turned down, Bill Lis, CEO of Portola, expressed the firm’s intentions in the following statement: “Because AndexXa addresses an urgent unmet medical need, we and the FDA are committed to resolving the outstanding questions and determining appropriate next steps. 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 injuries and deaths
Since hitting the shelves in 2011, Xarelto has been associated with a large number (more than 2,000) of adverse events related to internal bleeding. In addition, dozens of Xarelto patients have died from uncontrolled hemorrhaging. With no effective bleeding antidote at their disposal, Xarelto patients are at risk for life-threatening injury. It is argued that Johnson & Johnson/Bayer manufactured and marketed Xarelto without sufficient warnings, and even promoted the drug as a safer alternative to Coumadin (warfarin).
Thousands of patients have pursued Xarelto litigation after suffering serious harm or the loss of a loved one. According to Xarelto lawsuits and adverse event reports submitted to the FDA, the blood thinner is associated with a high risk of:
- Gastrointestinal bleeding
- Cerebral hemorrhage and vascular accidents
- Hemorrhagic stroke
- Peripheral edema
- Uncontrolled bleeds requiring hospitalization and transfusion
The law firm of Nadrich & Cohen, LLP believes that Big Pharma owes a duty to label their products correctly and inform consumers about known health risks. When this obligation is breached, victims have the right to pursue a product liability claim, or in some cases, a wrongful death lawsuit.
To learn more about filing a Xarelto bleeding claim, we invite you to schedule a free consultation. Call 1-800-718-4658 to speak with a skilled California personal injury lawyer today.
Additional Xarelto Resources:
- PharmaTimes, Portola’s blood thinner antidote turned away by FDA http://www.pharmatimes.com/news/portolas_blood_thinner_antidote_turned_away_by_fda_1102641
- ThePharmaLetter.com, FDA rejects Portola’s anticoagulant antidote AndexXa http://www.thepharmaletter.com/article/fda-rejects-portola-s-anticoagulant-antidote-andexxa