The filing is based on data from two phase 3 ANNEXA studies, and limited efficacy and safety data from the ongoing phase 3b/4 ANNEXA-4 study. The company is seeking conditional approval in patients treated with a Factor Xa inhibitor such as Johnson & Johnson/Bayer’s Xarelto (rivaraxoban), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding and for patients requiring urgent or emergency surgery.Įurope’s CHMP has begun its standard 210-day review period. dailymed/drugInfo.Portola has said European regulators are to review its anticoagulant antidote, IndexXa (andexanet alfa), just days after the US regulator rejected the drug.Ĭalifornia-based Portola said the European Medicines Agency had accepted its filing for the Factor Xa inhibitor antidote. Xarelto - rivaroxaban and rivaroxaban tablet, film coated.Warfarin sodium - warfarin sodium tablet.Savaysa - edoxaban tosylate tablet, film coated.Pradaxa - dabigatran etexilate mesylate capsule.diseases-and-conditions/more-antidotes-for-newer-blood-thinners More antidotes for new blood thinners.diseases-conditions/deep-vein-thrombosis/symptoms-causes/syc-20352557 Eliquis - apixaban tablet, film coated.Pros and cons of new oral anticoagulants. fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/andexxa-coagulation-factor-xa-recombinant-inactivated-zhzo ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo).You can learn more about how we ensure our content is accurate and current by reading our editorial policy. Healthline has strict sourcing guidelines and relies on peer-reviewed studies, academic research institutions, and medical associations. This is called a pulmonary embolism, and it may be fatal. Then, it can enter the small blood vessels of your lungs, where it can lodge and block your blood flow.
If it breaks loose, it can flow in your bloodstream through your heart. If you don’t treat DVT, the clot can get bigger and break loose. Whether your doctor prescribes warfarin or one of the new alternatives to prevent or treat your DVT, it’s important that you follow the therapy. People who have a condition that affects how the blood clots may also be at risk for DVT. These might be people who have just had surgery, people who have been in an accident that’s limited their movement, or people who are older and may not move around as much. This is especially true in your larger veins, which carry more blood.ĭVT is more likely to happen in people who move less than normal. When your blood flow is slower than normal, the risk of blood cells clumping together in your blood vessels is greater. If you’re moving less than normal, your blood flow becomes even slower. The blood flow in your veins is slower than the blood flow in your arteries because it doesn’t have as much momentum from your heartbeat. DVT is a blood clot that forms in one or more large deep veins in your body, usually your legs.
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