The drug was twice denied approval and the FDA wanted additional data before approval could take place. Patients with artificial heart valves should not take the drug as it was not studied in that population yet. Bristol-Meyers Squibb is the manufacturer and it will be co-marketed with Pfizer. They are a little late to the game as Pradaxa was approved about 2 years ago as an alternative for Warfarin. There are no regular blood tests required to monitor as there is with Warfarin. Eliquis could prove to be better drug however since it is in a newer class of drugs. In addition there is Xarelto that also competes in this arena. In the clinical trial of 18,000 patients those taking Eliquis had fewer strokes. BD
FDA Approves Pradaxa–An Alternative to Warfarin To Treat Blot Clots Associated With Atrial Fibrillation
WASHINGTON (AP) - The Food and Drug Administration said Friday that it approved an anticlotting drug called Eliquis, developed by Bristol-Myers Squibb Co. and Pfizer Inc. It's a potential blockbuster in a new category of medicines to prevent strokes.
The agency previously rejected the drug twice, most recently in June, awaiting additional data from company trials.
The FDA cleared the pill for treating the most common type of irregular heartbeat, atrial fibrillation, in patients at risk for strokes or dangerous clots.