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. 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. Portola Pharmaceuticals developed AndexXa to reverse the anticoagulant effects of a new and fast-growing class of drugs known as factor Xa inhibitors.įactor Xa inhibitors' advantages have turned Xarelto and Eliquis into multibillion-dollar-per-year blockbusters already. 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.Īnd 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.įrom this Augarticle, "Is It " Game Over" After Portola's FDA Rejection?", posted on The Motley Fool website, we get this contextual information: Savaysa (edoxaban) from Daiichi Sankyo.Xarelto (rivaroxaban) from Bayer/Johnson & Johnson and,.Eliquis (apixaban) from Pfizer/Bristol-Myers Squibb.
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:
Portola, Which Developed AndexXa, Estimates 100,000 Patients Per Year Suffer From Severe Uncontrollable Bleeding Events That Could Require Such An Antidote
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