Twice now, Portola Pharmaceuticals submitted their groundbreaking Xarelto and Eliquis antidote for FDA approval. While the U.S. Food and Drug Administration postponed its approval twice, they’ve now approved it for U.S. patients. The drug’s name is AndexXa — and it fills a crucial market need.
Portola first sought FDA approval for AndexXa in August 2016. However, the FDA wanted more information about it before granting approval. Specifically, they asked Portola Pharmaceuticals for manufacturing and data on two other drugs — edoxaban and enoxaparin. After re-submitting, Portola Pharmaceuticals asked the FDA for an update in February 2018. However, the FDA delayed AndexXa’s approval until May 4, 2018.
FDA Asks Portola Pharmaceuticals to Submit Additional Information About AndexXa
The South San Francisco biotech company recent told Portola Pharmaceuticals investors this dismaying news. While Portola Pharmaceuticals expected approval in February 2018, they didn’t get their wish. Apparently, the FDA needs to consider additional information from Portola Pharmaceuticals before moving forward with approval. Manufacturing details seem to be the holdup.
Portola’s investors are anxiously awaiting approval. Pfizer and Bristol-Myers each provided Portola Pharmaceuticals with $25 million in unsecured loans. The goal was to help cover the costs of development and clinical studies. Once the drug gains FDA approval, all three companies have marketing agreements in place for the reversal agent.
Portola Pharmaceuticals Cites Urgent Need for AndexXa Approval
But the FDA’s delay is affecting more than just Portola and its investors. AndexXa is in development to treat excessive bleeding in patients who take popular blood thinners Eliquis and Xarelto. Doctors often prescribe both drugs — despite their lack of an antidote. Prior to the Eliquis and Xarelto launch, patients were nearly universally prescribed warfarin. Warfarin, the tried and true drug has multiple reversal agents. Vitamin K, prothrombin complex concentrate (PCC) and fresh frozen plasma (FFP) are all effective antidotes. If a patient experiences uncontrollable bleeding or requires emergency surgery, doctors administer these antidotes.
For patients taking Eliquis and Xarelto however, no antidotes are available. These medications leave patients susceptible to bleeding out should an injury occur. As a result, thousands of patients are at risk every day. Lawsuits are underway against drug manufacturers Johnson & Johnson and Bayer for undisclosed bleeding risks.
Had Serious or Uncontrolled Bleeding With Xarelto?
Thousands of patients are currently susceptible to serious risks — including death. And severe bleeding risks will continue for now, since no FDA-approved antidote exists. Across the nation, lawyers are filing suits against pharmaceutical companies. In an SEC filing, J&J said the number of Xarelto lawsuits grew 27% in the last year. And the drug is now linked to at least 370 deaths. It’s no wonder, then, that the drug giants Bayer and J&J are eager for Portola Pharmaceuticals to secure AndexXa’s approval.
UPDATE: Portola Pharmaceuticals Gains FDA’s Approval for AndexXa in May 2018
Since we originally published this post, the FDA reviewed and finally approved AndexXa on May 4, 2018. This drug is the first Factor Xa antidote approved to reverse anticoagulation effects in Xarelto and Eliquis patients.
How Xarelto Bleeding Victims Can Get the Justice and Compensation They Deserve
If you or a loved one took Xarelto and experienced uncontrolled bleeding, you’re not alone. Join the 20,000+ lawsuits now waiting for trials. To see if you may qualify for a cash settlement, fill out your free Xarelto claim review now. Once you’ve submitted your information, a lawyer will call to discuss your case. This phone call is an important first step in getting the justice and compensation you deserve!
Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as Match.com, Yahoo!, MSN, AOL, Xfinity, Mail.com, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.