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Apixaban
Anticoagulant medication

Apixaban, sold as Eliquis, is an anticoagulant used to prevent blood clots and stroke in nonvalvular atrial fibrillation by directly inhibiting factor Xa. It offers an alternative to warfarin without requiring blood test monitoring or dietary restrictions and is taken orally. Common side effects include bleeding and nausea, with caution advised during pregnancy and breastfeeding. Developed by Pfizer and Bristol-Myers Squibb, it was approved in the EU (2011) and US (2012) and is listed on the WHO Essential Medicines. Apixaban is widely prescribed and available generically outside the US.

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Medical uses

Apixaban is indicated for the following:26

In the EU, apixaban is indicated for the prevention of venous thromboembolic events (VTE) in adults who have undergone elective hip or knee replacement surgery, the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF) with one or more risk factors, for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults, and for the prevention of recurrent DVT and PE in adults.27

Atrial fibrillation

Apixaban is recommended by the National Institute for Health and Clinical Excellence for the prevention of stroke and systemic embolism in people with non-valvular atrial fibrillation and at least one of the following risk factors: prior stroke or transient ischemic attack, age 75 years or older, diabetes, or symptomatic heart failure.28

Apixaban and other anticoagulants (dabigatran, edoxaban and rivaroxaban) appear equally effective as warfarin in preventing non-hemorrhagic stroke in people with atrial fibrillation and are associated with lower risk of intracranial bleeding.2930

While apixaban may be used in people with severely decreased kidney function and those on hemodialysis it has not been studied in these groups.31

Side effects

Bleeding

Apixaban can increase the risk of bleeding which may be serious and potentially fatal. Concurrent use with other medications that affect blood clotting can further increase this risk. This includes medications such as other anticoagulants, heparin, aspirin, antiplatelet medications, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs).32333435

Andexanet alfa is a US Food and Drug Administration (FDA) approved antidote for apixaban in people with uncontrolled and life-threatening bleeding events.3637

Spinal puncture

Following spinal anesthesia or puncture, people who are being treated with anti-thrombotic agents are at higher risk for developing a hematoma, which causes long-term or permanent paralysis. The risk of this may be increased by using epidural or intrathecal catheters after a surgical operation or from the concurrent use of medicinal agents that affect hemostasis.38

Mechanism of action

Apixaban is a highly selective, orally bioavailable, and reversible direct inhibitor of free and clot-bound factor Xa. Factor Xa catalyzes the conversion of prothrombin to thrombin, the final enzyme in the coagulation cascade that is responsible for fibrin clot formation.39 Apixaban has no direct effect on platelet aggregation, but by inhibiting factor Xa, it indirectly decreases clot formation induced by thrombin.40

History

Apixaban was approved for medical use in the European Union in May 2011.41

A new drug application (NDA) for the approval of apixaban was submitted to the US Food and Drug Administration (FDA) by Bristol-Myers Squibb (BMS) and Pfizer jointly after the conclusion of the ARISTOTLE clinical trial in 2011.4243 Apixaban was approved for the prevention of stroke in people with atrial fibrillation in December 2012.4445 In March 2014, it was approved for the additional indication of preventing deep vein thrombosis and pulmonary embolism in people who have recently undergone knee or hip replacement.4647 In August 2014, the FDA approved apixaban for the additional indication of the treatment of recurring deep vein thrombosis and pulmonary embolism.4849 During its development the drug was known as BMS-562247-01.50 By late 2019, sales of the product by BMS accounted for thirty percent of their quarterly revenue.51

Society and culture

Economics

In December 2019, the US FDA approved a generic version of apixaban produced jointly by Mylan and Micro Labs.525354 BMS and Pfizer worked quickly to block generics from being created, and in August 2020, they won a patent infringement lawsuit against Sigmapharm, Sunshine Lake, and Unichem, after previously settling patent cases against 25 other companies.5556 In September 2021, a Federal Circuit Court upheld the ruling.57 The result is that apixaban generics will most likely not be available in the United States until at least 2026, but possibly 2031.58

In July 2022, the Canadian generic drug company, Apotex Inc., obtained approval for marketing of apixaban.5960

Pfizer reported revenue of US$6.747 billion for Eliquis in 2023.61

Apixaban is one of ten medications covered by price negotiations in the US under the Inflation Reduction Act. The negotiations, conducted by the Centers for Medicare & Medicaid Services, apply to pricing for Medicare recipients. The results of the negotiations were announced in August 2024, and Medicare's negotiated price for a 30-day supply of Eliquis is $231, a 56% decrease from the 2023 list price of $521.62 The pricing is set to take effect in 2026.6364

References

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  2. British national formulary: BNF 76 (76 ed.). Pharmaceutical Press. 2018. pp. 124–125. ISBN 9780857113382. 9780857113382 ↩

  3. "FDA approves first generics of Eliquis". U.S. Food and Drug Administration (FDA). 23 December 2019. Archived from the original on 23 December 2019. Retrieved 23 December 2019. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-eliquis ↩

  4. "Apixaban Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Retrieved 27 March 2019. https://www.drugs.com/monograph/apixaban.html ↩

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  7. Hall H (September–October 2020). "How a Drug Is Born". Skeptical Inquirer. Amherst, New York: Center for Inquiry. /wiki/Harriet_Hall ↩

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  13. British national formulary: BNF 76 (76 ed.). Pharmaceutical Press. 2018. pp. 124–125. ISBN 9780857113382. 9780857113382 ↩

  14. British national formulary: BNF 76 (76 ed.). Pharmaceutical Press. 2018. pp. 124–125. ISBN 9780857113382. 9780857113382 ↩

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  17. "Bristol-Myers Squibb and Pfizer Announce Worldwide Collaboration to Develop and Commercialize Anticoagulant and Metabolic Compounds" (Press release). Pfizer. Archived from the original on 10 September 2015. Retrieved 25 December 2021. https://www.pfizer.com/news/press-release/press-release-detail/bristol_myers_squibb_and_pfizer_announce_worldwide_collaboration_to_develop_and_commercialize_anticoagulant_and_metabolic_compounds ↩

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