Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Eliquis (apixaban) be granted marketing authorization for the treatment of DVT (deep vein thrombosis) and PE (pulmonary embolism), and the prevention of recurrent DVT and PE, in adults. The CHMP’s positive opinion will now be reviewed by the European Commission (EC). The decision on whether to approve Eliquis for this indication will be made by the EC and will be applicable to all European Union member states plus Iceland and Norway.
The positive opinion was based on the results from the pivotal AMPLIFY and AMPLIFY-EXT studies. AMPLIFY ( Apixaban for the initial Management of Pu Lmonary embol Ism and deep vein thrombosis as First-line therap Y), a randomized, double-blind, multicenter trial, included 5,395 patients (2,691 were randomized to Eliquis and 2,704 were randomized to standard of care, which was initial enoxaparin treatment overlapped by warfarin therapy) with confirmed symptomatic DVT or PE requiring treatment for six months, and evaluated Eliquis therapy compared to standard of care. The primary efficacy endpoint was the composite endpoint of recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE-related death. The primary safety endpoint was the incidence of major bleeding compared to standard of care.
AMPLIFY-EXT ( Apixaban after the initial Management of Pu Lmonary embol Ism and deep vein thrombosis with First-line therap Y- EXTended Treatment), a randomized, double-blind, multicenter trial, included 2,486 patients (842 were randomized to Eliquis 2.5 mg, 815 were randomized to Eliquis 5 mg and 829 were randomized to placebo) with prior VTE who had completed six to 12 months of anticoagulation treatment for DVT or PE, and evaluated Eliquis therapy compared to placebo. The primary efficacy endpoint was reduction of the composite of symptomatic, recurrent VTE and death from any cause. The primary safety endpoint was the incidence of major bleeding.
|IMPORTANT SAFETY INFORMATION|
|WARNINGS: (A) DISCONTINUING ELIQUIS IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE, (B) SPINAL/EPIDURAL HEMATOMA|
|(A) Discontinuing ELIQUIS places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with ELIQUIS must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered .|
|(B) When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins, heparinoids, or Factor Xa inhibitors for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.|
|The risk of these events may be increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet aggregation inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.|
|Monitor patients for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary. Consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.|
- Active pathological bleeding
- Severe hypersensitivity reaction to ELIQUIS (apixaban) (e.g., anaphylactic reactions)
- Increased Risk of Stroke with Discontinuation of ELIQUIS in Patients with Nonvalvular Atrial Fibrillation: Discontinuing ELIQUIS in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If ELIQUIS must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.
- Bleeding Risk: ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal bleeding. Concomitant use of drugs affecting hemostasis increases the risk of bleeding including aspirin and other anti-platelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs. Patients should be made aware of signs or symptoms of blood loss and instructed to immediately report to an emergency room. Discontinue ELIQUIS in patients with active pathological hemorrhage.
- There is no established way to reverse the anticoagulant effect of apixaban, which can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). A specific antidote for ELIQUIS is not available. Hemodialysis does not appear to have a substantial impact on apixaban exposure. Protamine sulfate and vitamin K would not be expected to affect the anticoagulant activity of apixaban. There is no experience with antifibrinolytic agents (tranexamic acid, aminocaproic acid) in individuals receiving apixaban. There is neither scientific rationale for reversal nor experience with systemic hemostatics (desmopressin and aprotinin) in individuals receiving apixaban. Use of procoagulant reversal agents such as prothrombin complex concentrate, activated prothrombin complex concentrate, or recombinant factor VIIa may be considered but has not been evaluated in clinical studies. Activated charcoal reduces absorption of apixaban thereby lowering apixaban plasma concentrations.
- Prosthetic Heart Valves: The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart valves and is not recommended in these patients.
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