The US FDA recently approved the Prior Approval Supplement for Bevyxxa in advance of the anticipated date. If […] ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed, due to life-threatening or uncontrolled bleeding. In the guidance statement, ACEP highlighted Andexxa ® [coagulation factor Xa (recombinant), inactivated-zhzo] as a first-in-line, U.S. Food and Drug Administration (FDA) approved reversal agent for patients treated with apixaban or rivaroxaban, as compared to 4F-PCC, which are highlighted as a second-in-line option for Factor Xa reversal and recommended for use only if Andexxa … Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations and was initially approved on May 3, 2018 under the FDA's Accelerated Approval pathway. Approval of andexanet alfa was based on the results of two randomized, placebo-controlled trials (ANNEXA-A and ANNEXA-R) that evaluated the mean change from baseline in anti-factor Xa activity following administration of andexanet alfa to healthy volunteers 50-75 years old who had received either apixaban or rivaroxaban. The availability of Andexxa will help in their competition with Boehringer Ingelheim, whose blood thinner Pradaxa had a bleeding reversal agent approved in 2015. The approval of Andexxa is supported by data from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A) published in The New England Journal of Medicine, which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy volunteers (Figure 1 and Figure 2, respectively). To date, the pattern of antibody response in patients in the ongoing ANNEXA-4 study has been similar to that observed in healthy volunteers. AndexXa counteracts the effects of Factor Xa inhibitors, helping to thicken the blood and prevent serious uncontrolled or life-threatening bleeding events. Action Date Set for December 31, 2018. Currently, there is no FDA-approved antidote for Factor Xa inhibitors. None of these anti-ANDEXXA antibodies were neutralizing. FDA Approval Andexxa was approved under the FDA's Accelerated Approval pathway. The data demonstrated that Andexxa was associated with a lower … P ortola received approval for the Prior Approval Supplement (PAS) for the Gen 2 manufacturing process for AndexXa on the PDUFA date of December 31, 2018. AndexXa approval (1) AndexXa approval on May 4 (1) Andexxa launch (3) Andexxa PDUFA date and launch (1) Andexxa sequential sales drop in 4Q (1) Antares (9) Antares comments on Type A meeting with FDA (1) Antares Pharma Inc. (81) Antares Pharmaceuticals (1) Antares Presentation at Jefferies (1) Antares response to Complete Response Letter (1) The BLA seeks initial approval of AndexXa for reversal of the anticoagulant effects of apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding. Of the 236 subjects with available samples, 6.8% (16/236) had antibodies against ANDEXXA. In 2016, approximately 90,000 patients in the U.S. treated with oral Factor Xa inhibitors were subsequently admitted to the hospital due to bleeding. The new BLA for the drug has a target action date of Feb. 2. U.S. FDA Assigns PDUFA Date to Portola Pharmaceuticals’ Prior Approval Supplement for the Large-Scale Generation 2 Andexxa Process ; The now OK'd manufacturing process should enable Portola to launch Andexxa more widely than it has been able to do to date, the company said. 1 This approval allows full commercial launch for Andexxa, which was previously launched under an Early Supply Program with Generation 1 product. Management had expressed confidence in approval but in dealing with the FDA, it is never over until it’s over. It is given by injection into a vein.. Common side effects include pneumonia and urinary tract infections. The PAS has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 31, 2018. Portola Pharmaceuticals (NASDAQ: PTLA) long-awaited FDA decision on AndexXa could once again be delayed. As a result, the FDA's decision date on AndexXa was pushed back from Feb. 3, 2018 to May 4, 2018. Portola Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Company’s Prior Approval Supplement (PAS) filing for the large-scale Generation 2 manufacturing process for Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo]. If approved, AndexXa should go on to be an important and lucrative niche drug. It has not been found to be useful for other factor Xa inhibitors. The analysis compared a clinical scenario with Andexxa – the first and only antidote approved by the U.S. Food and Drug Administration (FDA) for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding – to one without it where patients were given 4-Factor Prothrombin Complex Concentrate (4F-PCC), which … On Feb. 28, the company reported on its earnings conference call that the FDA has requested additional information, and this week, at the American College of Cardiology's 67th Annual Scientific Session & Expo., management updated investors on what that request may mean to AndexXa's approval. We model approval of Berubicin for treatment of recurrent glioblastoma in 2025 based on the Phase 2 data with 55% probability of success for approval. Officials with the FDA approved Portola Pharmaceuticals’ Prior Approval Supplement (PAS) for the Generation 2 manufacturing process for Andexxa [ coagulation factor Xa (recombinant), inactivated-zhzo], according to a press release. This indication is approved under accelerated approval based on the change from baseline in anti-human Factor Xa activity in healthy volunteers. U.S. FDA Assigns PDUFA Date to Portola Pharmaceuticals’ Prior Approval Supplement for the Large-Scale Generation 2 Andexxa Process (1) This indication is approved under accelerated approval based on Action Date Set for December 31, 2018. Portola Pharmaceuticals Provides Update on Biologics License Application (BLA) for AndexXa (andexanet alfa) SOUTH SAN FRANCISCO, Calif., Dec. 22, 2017 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, (Nasdaq:PTLA) today announced that the U.S. Food and Drug Administration (FDA) will extend its review of the Biologics License Application (BLA) for AndexXa ® (andexanet alfa) by 90 days. If approved, it would be the first antidote for Factor Xa inhibitors on the U.S. market. Andexanet alfa, sold under the trade name Andexxa among others, is an antidote for the medications rivaroxaban and apixaban, when reversal of anticoagulation is needed due to uncontrolled bleeding. The approval of Andexxa was based on two Phase 3 studies (ANNEXA-R and ANNEXA-A), which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of … Low titers of anti-ANDEXXA antibodies were observed in 26/145 healthy subjects (17%); 6% (9/145) were first observed at Day 30 with 20 subjects (14%) still having titers at the last time point (Days 44 to 48). SOUTH SAN FRANCISCO, Calif., March 16, 2020 /PRNewswire/ -- Portola Pharmaceuticals, Inc. ® (Nasdaq: PTLA) today announced new data reinforcing the value of Andexxa ® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only FDA-approved reversal agent for the Factor Xa inhibitors rivaroxaban or apixaban. In the CRL for AndexXa, the FDA requested that Portola provide additional information primarily related … Continued approval for this indication may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients. To date, the pattern of antibody response in patients in the ongoing ANNEXA-4 study has been similar to that observed in healthy volunteers. Dive Brief: The Food and Drug Administration this week approved Portola Pharmaceuticals' second generation manufacturing process for Andexxa, the company's reversal agent for Factor Xa inhibitors Eliquis and Xarelto. ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
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