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After two years of delays and uncertainty, Portola Pharmaceuticals reports that federal regulators have finally approved a reversal agent that may help prevent many deadly bleeding events linked to side effects of Xarelto and Eliquis, two new generation anticoagulants that have already been widely adopted by the medical community.
The drug manufacturer issued a press release on Friday, announcing that the FDA has approved Andexxa, an antidote for the reversal of Factor Xa inhibitors, which includes Xarelto and Eliquis. However, the company notes that the approval is through the U.S. Orphan Drug and FDA Breakthrough Therapy designations, and warns that the results of post-marketing studies on the drug’s effectiveness and safety will determine if it stays on the market.
The postmarketing study requirement involves a clinical trial and is scheduled to start in 2019, and must be completed by 2023. However, that is just a year before Xarelto’s patent expires in 2024, and postmarketing studies are often delayed or never completed, according to a 2013 study.
Xarelto and Eliquis were introduced as a replacement for warfarin as a preventative treatment for strokes and other problems linked to atrial fibrillation. However, the two drugs have been linked to thousands of reports involving severe and fatal injuries, when users experienced bleeding that doctors were unable to stop or reverse.
Unlike warfarin, which can be quickly reversed with a known antidote, no approved reversal agent for Xarelto has been available since the drug was introduced in 2011.
Portola Pharmaceuticals has been working to convince the FDA to approve AndexXa for nearly two years.
FDA officials have been cautious about the reversal agent, which may be used by millions of patients, and have called for more evidence that it is safe and effective. In addition, a 2016 study showing positive results for AndexXa (andexanet alfa) has come under scrutiny by doctors, who say that the study’s researchers may have been overstating its benefits.
Incidents of unstoppable bleeding have resulted in injury and death for patients using the new drugs. Currently, there are about 20,000 Xarelto bleeding lawsuits pending as part of a federal multidistrict litigation (MDL), which is centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana. Each of the claims raise similar allegations that users and the medical community were not adequately warned about the risk of uncontrollable bleeding on Xarelto.
Following a handful of early bellwether trials, which were held before Judge Fallon to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, no progress has been made in negotiating Xarelto settlements or another resolution for the claims.
As a result, Judge Fallon recently ordered the parties to select 1,200 Xarelto cases for discovery, which may then be remanded back to U.S. District Courts nationwide for individual trial dates later this year.