FDA News

Second-generation antidote for two direct oral anticoagulants approved

Portola Pharmaceuticals announced that the FDA approved its Prior Approval Supplement for the second generation of andexanet alfa, allowing for its broad commercial launch in the U.S.

Andexanet alfa (Andexxa, Portola) is an antidote for patients treated with rivaroxaban (Xarelto, Janssen) or apixaban (Eliquis, Bristol-Myers Squibb) who require anticoagulation reversal due to uncontrolled or life-threatening bleeding, according to a press release from the company.

The use of the antidote is increasing due to the safety and efficacy profile of rivaroxaban and apixaban compared with warfarin and enoxaparin to treat and prevent conditions such as pulmonary embolism, stroke and venous thromboembolism, according to the press release.

As Cardiology Today previously reported, the antidote was approved by the FDA last year, which was based on results from the phase 3 ANNEXA studies.

Portola Pharmaceuticals announced that the FDA approved its Prior Approval Supplement for the second generation of andexanet alfa, allowing for its broad commercial launch in the U.S.
Source: Adobe Stock

“It is clear from the response to the Andexxa Early Support Program that there is significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the factor Xa inhibitors apixaban and rivaroxaban,” Scott Garland, president and CEO for Portola, said in the press release.

Disclosure: Garland is an employee of Portola.

Portola Pharmaceuticals announced that the FDA approved its Prior Approval Supplement for the second generation of andexanet alfa, allowing for its broad commercial launch in the U.S.

Andexanet alfa (Andexxa, Portola) is an antidote for patients treated with rivaroxaban (Xarelto, Janssen) or apixaban (Eliquis, Bristol-Myers Squibb) who require anticoagulation reversal due to uncontrolled or life-threatening bleeding, according to a press release from the company.

The use of the antidote is increasing due to the safety and efficacy profile of rivaroxaban and apixaban compared with warfarin and enoxaparin to treat and prevent conditions such as pulmonary embolism, stroke and venous thromboembolism, according to the press release.

As Cardiology Today previously reported, the antidote was approved by the FDA last year, which was based on results from the phase 3 ANNEXA studies.

Portola Pharmaceuticals announced that the FDA approved its Prior Approval Supplement for the second generation of andexanet alfa, allowing for its broad commercial launch in the U.S.
Source: Adobe Stock

“It is clear from the response to the Andexxa Early Support Program that there is significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the factor Xa inhibitors apixaban and rivaroxaban,” Scott Garland, president and CEO for Portola, said in the press release.

Disclosure: Garland is an employee of Portola.