Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ELIQUIS is a factor Xa inhibitor indicated: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. FDA label
Apixaban · 2 trials · 3 indications
Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.
Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.
| Arm | Type | Description |
|---|---|---|
| Apixaban | EXPERIMENTAL | - |
| UFH/Warfarin | ACTIVE_COMPARATOR | - |
| Apixaban 5mg BID | EXPERIMENTAL | - |
| Apixaban 2.5mg BID | EXPERIMENTAL | - |
| Warfarin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Apixaban | DRUG | 10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks) |
| Unfractionated Heparin (UFH) | DRUG | Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more |
| Warfarin | DRUG | Dosing for 24 weeks to target INR range between 1.5-2.5 |
| Warfarin sodium | DRUG | At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks |
Inclusion Criteria: * Acute symptomatic proximal DVT with evidence of proximal thrombosis * Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches Exclusion Criteria: * Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA. * Unco...
Top 3 of 12 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 5 | PHASE3 | REGN7508, REGN9933 |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE2 | Thrombate III |
| Johnson & Johnson | JNJ | 1 | - | Rivaroxaban |
Apixaban is a small molecule drug developed by Pfizer, Inc. (ticker: PFE) for cardiovascular conditions. It has been studied in atrial fibrillation and deep vein thrombosis, and is being investigated as an inhibitor of factor X (F10).
Apixaban has been studied for use in atrial fibrillation, a condition characterized by irregular heartbeats. A Phase 2 clinical trial (NCT00787150) evaluated its safety in patients with atrial fibrillation, and it is also being investigated for deep vein thrombosis.
Apixaban targets factor X (F10), a key enzyme in the blood coagulation cascade. As an inhibitor of F10, it works by directly blocking this target to exert its anticoagulant effects.
Apixaban is being developed by Pfizer, Inc., a pharmaceutical company traded under the ticker symbol PFE. Pfizer is responsible for the clinical development of apixaban in cardiovascular indications.
Apixaban is in Phase 2 clinical development for atrial fibrillation, with a completed Phase 2 trial (NCT00787150). It has also been tested in a Phase 3 trial for deep vein thrombosis and pulmonary embolism, but it is not approved for these indications.
Apixaban has been evaluated in clinical trials including NCT00787150, a completed Phase 2 study in atrial fibrillation, and NCT01780987, a completed Phase 3 study in Japanese patients with acute deep vein thrombosis and pulmonary embolism.