The U.S. FDA (Food and Drug Administration) has reportedly made headlines after it recently approved the first generic versions of Eliquis (apixaban) tablets in the U.S. The generic tablets are formulated to decrease the risk of stroke and systemic embolism with nonvalvular atrial fibrillation (AFib) patients.

These tablets are indicated for the prophylaxis of DVT (deep vein thrombosis) which may lead to PE (pulmonary embolism) in patients who have undergone knee or hip replacement surgery. They are also indicated for PE and DVT treatment to reduce the risk of recurrent PE and DVT following initial therapy. 

According to Janet Woodcock, M.D., Director at FDA’s Center Drug Evaluation and Research, said that the approval of the first generic versions of Eliquis is an example of how FDA’s generic drug program gives better access to safe, high quality and low-cost medicines. Woodcock added that this is the first generic approval of a direct oral anticoagulant.

Apparently, addressing generic drug development challenges and promoting generic drug competition is a vital part of the FDA’s Drug Competition Action Plan. Under this program, the agency is helping patients by giving access to affordable drugs. The approval was granted to Mylan Pharmaceuticals Inc. and Micro Labs Ltd, said the agency.

Meanwhile, reports cite that sales of Apixaban, which was co-developed by Bristol-Myers and Pfizer, rose around 22% to USD 1.93 billion and made up around 30% of the total revenue of Bristol-Myers in the last reported quarter. 

For the uninitiated, atrial fibrillation (AFib) is a heart rhythm issue that can potentially cause blood clots. According to CDC, between 2.7 million and 6.1 million people in the U.S. suffer from atrial fibrillation. Many of its patients use anti-clotting or anticoagulants drugs to reduce its risk.

Source Link - https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-eliquis