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Despite what the manufacturers say is a high need and anticipation for the drug, Portola Pharmaceuticals indicates that AndexXa, it’s reversal agent for Xarelto and Eliquis, will only be available in about 40 to 50 hospitals until at least next year.
The announcement came from Portola CEO Bill Lis on a call to investors the day after the company announced that the FDA had approved AndexXa as an antidote for Factor Xa blood thinner effects, which would allow doctors to reverse uncontrollable bleeding problems linked to the new-generation anticoagulants.
While the FDA has approved the drug itself, Lis indicates that the FDA has not yet approved a new manufacturing process involved in making the product. The FDA raised questions about the process in its Complete Response Letter to the company, and the Portolo Pharmaceuticals had to revise the process.
Lis also noted that the company is still collecting data on the bioequivalence between AndexXa made by the two different manufacturing processes. However, the FDA appeared convinced enough to grant the drug’s approval last week.
Until the FDA approves the manufacturing process in question, AndexXa will only be provided at about 40 or 50 hospitals, and a few other locations, all of which served as clinical trial sites. Lis told investors that if the process is approved, it would then be available to about 1,000 different providers.
Xarelto and Eliquis were introduced as a replacement for warfarin as a preventative treatment for strokes and other problems associated with 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 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.