Portola, Which Developed AndexXa, Estimates 100,000 Patients Per Year Suffer From Severe Uncontrollable Bleeding Events That Could Require Such An Antidote
In mid-August 2016 the US FDA rejected Portola Pharmaceutical's application to market AndexXa (andexanet alfa) as an antidote to three direct Factor Xa inhibitors:
- Eliquis (apixaban) from Pfizer/Bristol-Myers Squibb;
- Xarelto (rivaroxaban) from Bayer/Johnson & Johnson; and,
- Savaysa (edoxaban) from Daiichi Sankyo.
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.
And these 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.
From this August 18, 2016 article, "Is It "Game Over" After Portola's FDA Rejection?", posted on The Motley Fool website, we get this contextual information:
Portola Pharmaceuticals developed AndexXa to reverse the anticoagulant effects of a new and fast-growing class of drugs known as factor Xa inhibitors....
Factor Xa inhibitors' advantages have turned Xarelto and Eliquis into multibillion-dollar-per-year blockbusters already. But the absence of an antidote that can reverse their anticoagulant effects has kept factor Xa inhibitors from being used in sickly and frail patients, which has limited the peak sales potential of this class of medicine.
To overcome that headwind and broaden the use of their drugs, Johnson & Johnson, Bristol-Myers Squibb, and Pfizer provided funding to Portola Pharmaceuticals so it could develop AndexXa. Until now, that's appeared to be money well spent, because clinical trials have proven AndexXa reverses the effects of both Xarelto and Eliquis....
Because of the big unmet need for an antidote to factor Xa drugs, the FDA awarded AndexXa breakthrough status and agreed to an accelerated review of AndexXa's filing. Portola Pharmaceuticals estimates that up to 100,000 factor Xa patients per year suffer from emergency events that could require a factor Xa antidote.
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For some reporting on the unexpected FDA denial of this AndexXa application, 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.”
We have previously written about the safety problems presented by the fact that there is currently no FDA-approved antidote or reversal agent for Eliquis, Savaysa, and Xarelto:
- Eliquis, Savaysa, And Xarelto Worry Doctors Because No Antidote, Still
- Eliquis Might Be Safer Than Xarelto, But Neither Has Approved Antidote
- No Antidotes For Eliquis, Savaysa, And Xarelto To Stop Acute Bleeding
- Eliquis Antidote Will Come Too Late For People Who Suffered Serious Bleeding Events, Some Which Caused The Deaths Of Patients
- Because No Antidote For Eliquis Is Available To Reverse The Effects Of Anticoagulation, There Have Been Irreversible Life-Threatening And Fatal Bleeding Events
- Eliquis And Xarelto, Like Pradaxa, Linked To Serious Bleeding Events Due To Fact No Antidote Available
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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