Last week, the U.S. Food and Drug Administration (FDA) shot down a blood thinner antidote produced by Portola Pharmaceuticals. However, this devastating blow to the company comes with some good news β the company might have better luck in Europe.
On Friday, Portola announced its application for approval to the European Medicines Agency (EMA) has been completed and accepted by the agency. Through the centralized review procedure, the EMA will have a 210-day review of the drug before deciding on approval.
The news undoubtedly allowed Portola to breathe a sigh of relief as the EMA is notoriously more generous with approvals than the U.S. FDA.
After announcing the acceptance of the EMA applications, Chief executive Bill Lis stated, βAn estimated 73,000 patients treated with an oral Factor Xa inhibitor will be hospitalized this year due to major bleeding or because they require urgent surgery in the EU5. These patients are critically ill and could potentially benefit from a Factor Xa inhibitor antidote.β
There is currently no consistent way to reverse the blood thinning effects of anticoagulants like Xarelto and Eliquis. Without an antidote, thousands of patients have suffered adverse bleeding events caused by this new generation of blood thinners.
Xarelto, manufactured by Janssen Pharmaceuticals and Bayer A.G., is responsible for the largest number of consumer complaints, The companies currently face more than 7,000 lawsuits alleging they failed to adequately warn patients and doctors of the bleeding risks associated with the drug.
Many plaintiffs in the Xarelto litigation feel that without an antidote, Xarelto is too dangerous to be on the market. While Xarelto has been a highly controversial drug since its approval, recent studies have found the drug causes more hemorrhages than other blood thinners currently on the market. The first cases in the Xarelto litigation to go to trial have been selected and are scheduled to begin in early 2017.