The U.S. Food and Drug Administration (FDA) has approved two applications for the first generics of the anticoagulant Eliquis (apixaban).
December 27, 2019 — The U.S. Food and Drug Administration (FDA) has approved two applications for the first generics of the anticoagulant Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (Afib or AF). Apixaban is also indicated 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. Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy.
The FDA granted approval of the generic apixaban applications to Micro Labs Limited and Mylan Pharmaceuticals Inc.
“Today’s approvals of the first generics of apixaban are an example of how the FDA’s generic drug program improves access to lower-cost, safe and high-quality medicines,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These approvals mark the first generic approvals of a direct oral anticoagulant. Direct oral anticoagulants do not require repeated blood testing.”
Apixaban is part of a class of novel oral anticoagulants (NOAC), which are also referred to as a direct oral anticoagulants (DOAC). They offer an alternative to warfarin (Coumadin), which has been generic for several years, but has a narrow therapeutic window so it requires regular INR testing to titrate the drug to maintain therapeutics levels.
Addressing the challenges related to developing generics and promoting more generic competition is a key part of the FDA’s Drug Competition Action Plan and the agency’s efforts to help increase patient access to more affordable medicines.
For at-risk patients, such as those with, or at risk for, DVT, or nonvalvular atrial fibrillation, the risk of stroke related to blood clots forming in the body and traveling to the brain is a serious concern. Atrial fibrillation is a heart rhythm problem that can potentially cause such blood clots. According to the Centers for Disease Control and Prevention (CDC), it is estimated that between 2.7 and 6.1 million people in the U.S. have Afib. Many of these individuals use anticoagulants or anti-clotting drugs to reduce that risk.
Apixaban will be dispensed with a medication guide for patients that provides instructions on its use and drug safety information. Healthcare professionals should counsel patients on signs and symptoms of possible bleeding, the FDA said.
There is an increased risk of thrombotic events, which occur when blood clots form inside a blood vessel, or strokes if a patient stops using apixaban too early. Additionally, epidural or spinal hematomas may occur in patients treated with apixaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Healthcare professionals should consider these risks when scheduling patients for spinal procedures.
Patients with prosthetic heart valves should not take apixaban nor should patients with atrial fibrillation that is caused by a heart valve problem. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with apixaban.
For more information: FDA First Generic Drug Approvals