FDA Delays Portola Pharmaceuticals AndexXa Review Until May 2018

Portola Pharmaceuticals

Twice now, Portola Pharmaceuticals submitted their groundbreaking Xarelto and Eliquis antidote for FDA approval. And the U.S. Food and Drug Administration continues to postpone the reversal agent’s approval for market. The drug’s name is AndexXa — and if it gains FDA approval, it will fill a crucial market need.

Portola anticipated approval for AndexXa in August 2016. However, the FDA is requesting further information about the drug. Specifically, they require more information about Portola’s manufacturing and data for two other anticoagulants in the label — edoxaban and enoxaparin. After re-submitting, Portola Pharmaceuticals expected an answer in February 2018. However, the FDA is delaying the reversal agent’s approval once again.

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, the action date is now set for May 2018. 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.

How Xarelto Bleeding Victims Can Get the Justice and Compensation They Deserve

If you or a loved one took Xarelto and suffered serious effects, you’re not alone. Join the 20,000 pending lawsuits currently awaiting trial. To see if you may qualify for a cash settlement from Xarelto’s manufacturer, fill out your free claim review now. Once you’ve submitted your information, an advocate will call to discuss how to get the justice and compensation you deserve.

Related: What No Xarelto Reversal Agent Means for Patients and Physicians