The following Factor Xa inhibitors, which serve as blood-thinner drugs, are being used by an increasing number of patients for stroke prevention and for treatment of deep vein thrombosis and pulmonary embolism:
- Eliquis (apixaban) from Pfizer/Bristol-Myers Squibb;
- Xarelto (rivaroxaban) from Bayer/Johnson & Johnson; and,
- Savaysa (edoxaban) from Daiichi Sankyo.
In mid-August 2016 the US FDA rejected Portola Pharmaceutical’s application to market AndexXa (andexanet alfa) as an antidote to these three direct Factor Xa inhibitors.
The reason this FDA rejection of the AndexXa application is remarkable: There is no reversal agent for Factor Xa inhibitors approved in the United States.
For some reporting on the unexpected FDA denial of this AndexXa new drug application (NDA), we turn to this August 18, 2016 article, “FDA rejects reversal agent for anticoagulation drugs”, from Healio CardiologyToday:
Portola Pharmaceuticals announced it received a complete response letter from the FDA that its reversal agent for Factor Xa inhibitor anticoagulants will not be approved at this time.
The agent, andexanet alfa (AndexXa), was developed for reversal of uncontrolled bleeding in patients treated with direct Factor Xa inhibitors such as apixaban (Eliquis, Bristol Myers-Squibb/Pfizer), edoxaban (Savaysa, Daiichi Sankyo) and rivaroxaban (Xarelto, Janssen Pharmaceuticals) and indirect Factor Xa inhibitors such as enoxaparin, according to a press release issued by the company. Factor Xa inhibitors are often used for stroke prevention in patients with nonvalvular atrial fibrillation and for treatment of deep vein thrombosis and pulmonary embolism.
There is no reversal agent for Factor Xa inhibitors approved in the United States; the FDA in 2013 designated andexanet alfa as a breakthrough therapy and in 2015 designated it as an orphan drug, both enabling expedited review….
“Because AndexXa addresses an urgent unmet medical need, we and the FDA are committed to resolving the outstanding questions to determine the appropriate next steps,” Bill Lis, CEO of Portola, said in the release. “We plan to meet with the FDA as soon as possible.”
At the present time it is unknown when Portola will be in a position to resubmit its AndexXa application to the FDA, much less when the FDA will make its next determination about AndexXa being approved, or not.
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