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- | Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Journal: Consensus document of the Sociedad Española de Patología Digestiva on massive nonvariceal gastrointestinal bleeding and direct-acting oral anticoagulants. (Pubmed Central) - Jul 17, 2022
the approach to these critically ill patients must be multidisciplinary and protocolized, optimizing decisions for an early identification of the condition and patient stabilization according to the tenets of damage control resuscitation. Thus, consideration must be given to immediate anticoagulation reversal, preferentially with specific antidotes (idarucizumab for dabigatran and andexanet alfa for direct factor Xa inhibitors); hemostatic resuscitation, and bleeding point identification and management.
- | AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Journal: Reversal of factor Xa inhibitors associated intracranial haemorrhage at a tertiary medical centre. (Pubmed Central) - Jul 15, 2022
The results of this study suggest that haemostasis and mortality at discharge during the index hospitalization appears to be similar between groups. Prospective randomized control trials comparing safety and efficacy of andexanet and 4F-PCC are needed.
- |||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
New trial: Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation) (clinicaltrials.gov) - Jul 12, 2022
P=N/A, N=300, Recruiting, Sponsor: AstraZeneca
- || Savaysa (edoxaban) / Daiichi Sankyo, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Clinical, Journal: Andexanet Alfa for Specific Anticoagulation Reversal in Patients with Acute Bleeding during Treatment with Edoxaban. (Pubmed Central) - Jul 8, 2022
Hemostatic efficacy was similar to that observed in patients with bleeding on rivaroxaban or apixaban. Thrombotic events occurred at a rate expected in such patients.
- || Savaysa (edoxaban) / Daiichi Sankyo, Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Review, Journal: Methods to Correct Drug-Induced Coagulopathy in Bleeding Emergencies: A Comparative Review. (Pubmed Central) - Jul 8, 2022
This review article also covers laboratory testing and is meant as a guide for physicians on best practices. These findings illustrate recommended testing and reversal techniques based off evidence-based medicine and literature.
- | Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Journal, HEOR: Costs and Healthcare Resource Utilization Associated with Idarucizumab or Andexanet Alfa Oral Anticoagulant Reversal in Patients Hospitalized with Life-Threatening Bleeds. (Pubmed Central) - Jul 7, 2022
However, a higher prevalence of ICH bleeds was noted in the andexanet alfa group. Trial Registration: Not applicable.
- ||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
https://t.co/ReVOm3YYxV First RWE showing AC reversal with Idarucizumab $13,000 cheaper than andexanet alfa, though populations differed #ISTH2022 #ZuckerSOM @PERTConsortium @NATFthrombosis @AnticoagForum @ThrombosisUK @EuropeanTHA @ThrombosisCan @canvector @escardio #thrombosis (Twitter) - Jul 6, 2022
- | AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Observational data, Journal: Andexanet Alfa for Reversal of Factor Xa Inhibitors in Intracranial Hemorrhage: Observational Cohort Study. (Pubmed Central) - Jun 25, 2022
There was no HE in the volumetric neuroimaging assessment in the AA-group, but clinical outcomes remained often worse. Large randomized trials for the use of AA in patients with acute FXa-inhibitor-associated ICH are needed to investigate the clinical outcome in consideration of the rates of thromboembolism.
- | AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Retrospective data, Journal: Andexanet alfa versus four-factor prothrombin complex concentrate for the reversal of apixaban- or rivaroxaban-associated intracranial hemorrhage: a propensity score-overlap weighted analysis. (Pubmed Central) - Jun 22, 2022
P3
In this indirect comparison of patients with an apixaban- or rivaroxaban-associated ICH, andexanet alfa was associated with better hemostatic effectiveness and improved survival compared to 4F-PCC. Trial registration NCT02329327; registration date: December 31, 2014.
- AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Whole Blood Microfluidics To Assess Direct Oral Anticoagulant (doac) Activity And Reversal In Neonatal Cardiac Patients (Salon B, Lower Level) - Jun 18, 2022 - Abstract #BCVS2022BCVS_284;
Trial registration NCT02329327; registration date: December 31, 2014. WB microfluidics demonstrated that post-operative neonates are hypercoagulable compared to the pre-operative state and are responsive to apixaban, the effects of which can be reversed with Andexanet.
- ||| FDA event: Always confused why off-label 4PCC for Pradaxa reversal never got as much controversy as Andexxa when Praxbind was also FDA approved based on a single-arm study with ecarin clotting / diluted thrombin time as the primary endpoint in REVERSE-AD. KCentra contains thrombin too, no? (Twitter) - Jun 2, 2022
- ||| Kcentra (plasma-derived prothrombin complex concentrate) / CSL Behring, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Clinical: Both the Annexa-A and Annexa-R demonstrated immediate and sustained drops in Xa levels (94%/92%) after andexanet in apix/riva pts vs placebo. But Kcentra Xa level in this pop are the same as placebo showing no impact on Xa levels - which is a measure of Apix/Riva inhibition (Twitter) - Jun 2, 2022
- ||| Kcentra (plasma-derived prothrombin complex concentrate) / CSL Behring, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
P2 data: There was no “standard of care” then and if there is a “standard of care” now, it is andexanet which has a higher level recommendation in multiple guidelines and guidance pubs. The Kcentra group are ignoring this fact. Where are the phase 2&3 trials with Kcentra in this pop? (Twitter) - Jun 2, 2022
- ||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
P2 data, P3 data: Clearly I touched a nerve but you were the one that initiated with the false information that andexanet was approved based off of two phase II trials. Maybe it was a typo so if you meant phase III, I apologize for that but there has been way too much mis-info on these threads (Twitter) - Jun 1, 2022
- ||| Kcentra (plasma-derived prothrombin complex concentrate) / CSL Behring, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Clinical: Great point. There are also several studies of equivalent level of evidence (e.g.Coleman C et al. Cohen AT et al) suggesting andexanet pts may have lower (10-15%) rates of mortality than those seen with aPCC/PCC. Makes sense since Andexanet has a known MOA while Kcentra doesn't (Twitter) - Jun 1, 2022
- ||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca, amiodarone / Generic mfg.
FDA event: I’m not “so sure PCC is working”. I’m also not sure Andexxa is working in my population - 90%+ surgery within 6h. The amiodarone comparison provides an analogy for politics/grandfathering of FDA approval. And come on Anti-Xa is not measured in ng/mL and RCTs take $$!! (Twitter) - May 29, 2022
- ||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
HEOR: Fueled by drug costs that led to unreasonable choices of anchoring and confirming that 4F-PCC purportedly “worked” despite having no comparator although ironically PCC folks beat up andexanet for having no comparator. The reason why there was no comparator was that the FDA knew (Twitter) - May 29, 2022
- ||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Retrospective data: The important difference between low and high quality evidence that a clinical trial demonstrates vs retrospective handpicked cases matched off of one variable with no blinding and multiple other limitations that affect the published outcomes and pretend to compare to andexanet (Twitter) - May 29, 2022
- || AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Some evidence courtesy of @CMichaelGibson, but not aware of andexanet vs PCC https://t.co/RJm95bkNo4 (Twitter) - May 28, 2022
- ||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Pricing, Reimbursement, HEOR: Andexxa’s WAC price was reduced by 55% last month—now ~$12k for 80-90% all doses…not including 340b discount for eligible institutions, J/C code billing if “drip-n-ship” from ED, or NTAP reimbursement up to ~$18k above DRG. Total cost of care is critical to consider big picture. (Twitter) - May 28, 2022
- || AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
I maintain a higher standard when a drug runs $25-50k per dose. PCCs are already costly, but it’s unjustifiable to charge 2-5x more and report nonclinical outcomes in a trial. There’s a reason Andexxa was not recommended for approval. (Twitter) - May 27, 2022
- || AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
🤔 Why isn’t Andexxa usual medical care 4 years later ? (Twitter) - May 26, 2022
- ||| Clinical, P3 data: The study is underway. It is called the Annexa-I which is a randomized controlled trial of andexanet vs usual medical care (a portion of which will contain 4F-PCC (Kcentra). The point is that 4F-PCC has done no phase 3 trials for rivaroxaban or apixaban bleeding treatment. (Twitter) - May 21, 2022
- ||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca, warfarin / Generic mfg.
Clinical: Do they need to for warfarin? For FXaIs I think the PCC dose has been pretty well established before Andexxa became available. Regarding efficacy, I think we’ll know more after ANNEXA-I is complete (Twitter) - May 20, 2022
- ||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
About 85-90% of andexanet dosing is playing out to be the low dose. So given many places and guidelines suggest weight based PCC dosing and 70% of Americans are obese/overweight, many situations may actually have PCC be more expensive than andexanet. (Twitter) - May 20, 2022
- || rivaroxaban / Generic mfg., AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca, apixaban / Generic mfg.
Although price shouldn’t be as much of an issue as it is in this arena, cost of andexanet has dropped by almost 60%(public knowledge). If my family or friends needed reversal for apixaban or rivaroxaban, I would absolutely want andexanet. I have seen horrible outcomes with 4FPCC (Twitter) - May 20, 2022
- || AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Higher quality level of evidence for andexanet consistently notes between multiple guidance/guideline statements - ACEP 2020 ACC2021 etc (Twitter) - May 20, 2022
- ||| Kcentra (plasma-derived prothrombin complex concentrate) / CSL Behring, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Clinical, P3 data: Andexanet phase 3b/4-93% reduction in FXa levels and an 82% hemostatic efficacy(HE) in a study enriched for ICH patients that we KNOW were actually anticoagulated. Kcentra - 0% reduction on FXa levels, no MOA, questionable rates of HE because we dont know if they are even on AC (Twitter) - May 20, 2022
- ||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Clinical: If andexanet alfa was released 4F-PCC price I think it would be formulary at every hospital. (Twitter) - May 20, 2022
- ||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
HEOR: I think it is totally reasonable for andexanet to get the 2a vs 2b . I don’t know any 4FPCC study that equals to be annexa-4 quality of study (and don’t think there is any) IMO the discussion is about cost/benefit economics between the two, which isn’t considered in LOE grade (Twitter) - May 20, 2022
- ||| P2 data, P3 data: Andexanet was approved based off of two phase 3 (not phase 2) Annexa A and Annexa R which showed a 92 and 97% immediate reduction in anti-FXa levels whereas KCentra hs no effect on FXa levels the whole reason we give apixaban and rivaroxaban ia to affect Xa levels. (Twitter) - May 20, 2022
- |||| Clinical: CSL Behring/Kcentra have not sat at the table with the FDA to study apixaban/rivaroxaban patients who are bleeding. Andexanet has. Clinicians should not give CSL Behring a “pass” on RCT clinical trials that they fund vs having clinicians do this for them. (Twitter) - May 20, 2022
- ||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Clinical: Dosing is well-defined for andexanet highlighting the difference of drugs who have undergone more rigorous clinical testing and continue to do so with the Annexa-I (Twitter) - May 20, 2022
- ||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca, dabigatran etexilate / Generic mfg.
Clinical: The level of evidence is similar for dabigatran and idarucizumab (praxbind). Dabigatran is only about 2-3% US marketshare of DOACs. Takeaway - if you are one of the 3500 or so US hospitals who stock prdxbind, you should be consistent and stock andexanet which are 80-90% DOAC use (Twitter) - May 20, 2022
- || Kcentra (plasma-derived prothrombin complex concentrate) / CSL Behring, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Similarly to ACEP Guidance 2020 and ACC 2021 guidance, Andexanet is first tier (2a) while 4F-PCC (2b) is second tier IF andexanet is not available. This shouldn't be interpreted as "Don't make andexanet available so we can use Kcentra" and continue to justify off-label Kcentra (Twitter) - May 20, 2022
- || Kcentra (plasma-derived prothrombin complex concentrate) / CSL Behring, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Annexa-I is underway and nearing the midway point of enrollment and randomizes andexanet vs Usual Medical Care (some of which will be Kcentra (4F-PCC) and has similar entry criteria to the Annexa-4. We may have information on this by late 2022. (Twitter) - May 20, 2022
- || AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
2a recommendation for andexanet alpha? Somebody doesn't know how to grade their recommendations appropriately. 2c, maybe. (Twitter) - May 19, 2022
- ||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
P2 data: That’s what gets me about andexxa. Basically approved on a phase II trial. Just do a real trial, it should be a slam dunk if it’s any good! (Twitter) - May 19, 2022
- || AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
There's no such thing as andexanet alfa! There is only coagulation factor Xa (recombinant), inactivated-zhzo. The AHA is committing science crimes. (Twitter) - May 19, 2022
- || AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
I mean the same organizations endorse thrombolytics for AIS with the strongest recommendation based on the highest quality evidence… the Andexxa thing doesn’t surprise me one bit (Twitter) - May 19, 2022
- || AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
One of the things that irks me. It's a national guideline, and they use Andexxa's made up name. Then they even spell that wrong in the picture... 🙄🙄 (Twitter) - May 19, 2022
- ||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca, desmopressin / Generic mfg.
🚨2022 AHA/ASA Guideline for Spontaneous ICH: 🔷 DOACs: Andexanet alfa (COR 2a )> 4FPCC (COR 2b) (Why? ANNEXA-4 is essentially a large case series) 🔷 VKAs: 4FPCC (fixed-dose PCC?) 🔷SBP goal <140 mmHg 🔷Antiplatelet-related ICH: ? desmopressin https://t.co/GBCptypFgR #TwitteRx (Twitter) - May 18, 2022
- || AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
FDA event: 2.5mg BID for prophylactic dose. Half life is short and there is a reversal agent (Andexxa) that was FDA approved in 2018. (Twitter) - May 14, 2022
- Savaysa (edoxaban) / Daiichi Sankyo, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca, CS-2100 / Daiichi Sankyo
Routine Measurement of Direct Factor Xa Inhibiting Anticoagulants (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_2266;
Target values for new batches of control are derived from parallel testing with the existing batch, with target SDs calculated from measurement uncertainty data.Performance in external quality assurance is acceptable for all analysers at all sites. Conclusion(s): Rivaroxaban, apixaban and edoxaban assays are now available routinely, with the same turnaround time as all other routine clotting assays at Trust sites where the assay is available.
- AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Effectivity of Andexanet Alfa for the Reversal of Factor Xa Inhibitors under Hemodilution (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1879;
Andexanet spiking of non-anticoagulated blood samples prolonged RVV test’s clotting time (CT) (Figure 2). Hemodilution prolonged clotting parameters further and reduced mean clot firmness (MCF).
- AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Direct comparison of Andexanet alfa and prothrombin complex concentrates in the reversal of direct factor Xa inhibitors – An in vitro study (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1855;
Clotting time and clot resistance to fibrinolytic breakdown was also corrected over the full range of applied FXaI (0-800 ng/ml). 4F-PCC in increasing dose (0.625, 1.25 and 2 IU/ml; ~25, 50 and 80 IU/kg) only partially restored thrombin generation lag time and clotting time.
- AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Assessing the reversal efficacy of prothrombin complex concentrate (PCC) and andexanet alfa in rivaroxaban-anticoagulated blood: Ex vivo study (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1744;
Independent of rivaroxaban concentration, andexanet normalized or overcompensated all TG parameters. PCC showed no significant improvement on TG.
- AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Andexanet alfa is associated with a significant reduction in in-hospital mortality compared to 4F-PCC in a real-world analysis (ExCel Center, ICC Capital Suite Room 8&9) - May 13, 2022 - Abstract #ISTH2022ISTH_1725;
Unadjusted baseline characteristics, including time since last anticoagulant dose, were similar between groups (Table 1). Gastrointestinal (GI) was the most common type of bleed, and most bleeds were spontaneous (Table 1).
- AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Differential Neutralization of Unfractionated Heparin and Enoxaparin by Andexanet Alfa (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1131;
The ANOVA test yielded a significant result when comparing the means of UFH treated at various andexanet alfa concentrations. The Tukey Post-Hoc test revealed significant differences between the UFH and UFH treated with andexanet alfa at all concentrations tested except at 6.25 μg/ml.
- AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
VALIDATION OF A TREATMENT DECISION ALGORITHM FOR THE USE OF ANDEXANET ALFA IN ACUTE LIFE-THREATENING BLEEDING FROM DIRCT FACTOR Xa INHIBITORS (ExCel Center, ICC Capital Suite Room 14-16) - May 13, 2022 - Abstract #ISTH2022ISTH_889;
Of the 100 patients, 7% had aXa activities 18 hours” (as applied in AA trials and used in clinical routine) would have excluded 12% from AA therapy, of whom 4 (33%) had aXa activities > 75 ng/ml. Table 1 indicates that, without an algorithm, the risk of over-treatment increases with increasing treatment indication thresholds.