Some exciting news for those on Blood Thinners for AF.
Abelacimab is a monoclonal antibody given just once a month by subcutaneous injection. It is not cleared by the kidneys, doesn’t require dose adjustments, and is not affected by other drugs. It achieves near-complete 99% inhibition of Factor XI over the entire month.
In afib patients, the 150 mg dose showed a 67% reduction in relevant bleeding compared to rivaroxaban, a highly significant 74% reduction in major bleeding, and a 93% reduction in gastrointestinal (GI) bleeding.
Because of these fantastic results, the Data Monitoring Committee (DMC) stopped the study early (back in September) due to such a substantial bleeding reduction. Since many people cannot take conventional anticoagulants, the hope is that abelacimab (and other Factor XI inhibitors) will address this pressing need for reducing stroke risk without causing bleeding.
The Food and Drug Administration (FDA) has granted abelacimab Fast Track Status for stroke prevention in those with afib due to this important unmet medical need.
"Some exciting news for those on Blood Thinners for AF."
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First of all, thank you for posting. Yes, exciting. And it's not only exciting news for those on blood thinners, but also exciting news for those who have chosen not to take blood thinners because of quality of life issues".
From the article...
"In our recent large patient survey, a considerable number of afib patients reported that bleeding and/or bruising problems since starting an anticoagulant had a significant impact on their quality of life. If approved, this could offer patients the protection they seek from strokes with minimal to no risk of bleeding.”
Let's just hope that the results hold up with the, now recruiting, phase 3 trial (Lilac-Timi 76 Study) where the other component -- stroke reduction -- will be more fully addressed.
Also exciting for those of us whose CHADVASC score that doesn't currently indicate use of blood thinners/anticoagulants. It's not that we (people with low CHADVASC scores) don't need protection from having strokes but the benefits are currently outweighed by the risks of major bleeding from the current range of blood thinners/anticoagulants. If the risks of using this new anticoagulant are significantly reduced and it provides the same/similar benefits then it should expand the scope for using it for younger AF sufferers.
Trying not to be negative about this promising news, and with the hope that stroke risks are also lowered, but I sense the cost of this type of mAb drug might still mean it is restricted to small cohorts of patients? Just wondering.
Ozziebob: Agree with you. Biologics don't come cheap!
Another issue is the one month dosing schedule. Sounds ideal, except for an untoward reaction, which could then last for a month! Sometimes shorter half lives are beneficial!
OB: " I sense the cost of this type of mAb drug might still mean it is restricted to small cohorts of patients?"
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Yes, for now while it's still in the trial phase, but hopefully it will be available to the public at large at a later time should the next stage of these trials be successful.
I am sorry I don't, just came across the article - its on fast track for FDA approval, so I imagine fairly soon. I am pretty sure there are other drugs researching targeting the Factor XI inhibitors
Still needs to go through a Phase III trial. The current trial shows that it reduces bleeds, but they need another trial to show that it prevents strokes on par with DOAC's.
Still needs a phase III trial to demonstrate that it prevents strokes on par with DOAC's, which is just starting to enroll, so it may be some time. 1-3 years?????
Don’t want to be a party pooper but I think another factor XI inhibitor (Asundexian) just failed dismally in the phase III Oceanic stroke trial which got stopped early due to lack of efficacy in preventing stroke. Reduced bleeding is great but not if the drug fails in its principal task.
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