Even though there was a lot of speculation that Apixaban was going to be approved by the FDA as an alternative treatment to Warfarin for stroke prevention in patients with AF, the regulators decided against approving the drug.
Bristol Meyers-Squibb and Pfizer, the makers of Apixaban, issued a joint statement saying that the FDA issued a complete response letter that asked the companies for more information on information management and proof from the ARISTOTLE trial.
“The FDA has not requested that the companies complete any new studies,” the statement notes. “FDA and the companies are committed to working expeditiously to address the outstanding questions and move the application forward.”
For now, there are two other alternative drugs that are approved for use in stroke and systemic embolism prevention in AF patients. Those medications include dabigatran (Pradaxa, Boehringer Ingelheim) and rivaroxaban (Xarelto, Bayer). Though not approved for this purpose yet, Apixaban is FDA approved in the European Union as a treatment for the prevention of venous thromboembolism in adults who are having knee and hip replacement surgery.
It should be noted that there was no advisory panel meeting held on Apixaban. When the application for approval was sent, it was primarily based on how the drug performed in the ARISTOTLE and AVERROES trials, which were both published in the New England Journal of Medicine. ARISTOTLE showed that Apixaban beat out Warfarin in stroke and systemic embolism prevention. This trial also revealed that Apixaban did all of this with less bleeding and lower death rates. That alone put Apixaban above Dabigatran and Rivaroxaban. The AVERROES trial showed that Apixaban prevented strokes and systemic embolism without causing more intracranial bleeding in the AF patients.
Another medication that is prescribed to AF patients is Multaq. These days, it seems more and more likely that Multaq will be recalled once other drugs like Apixaban prove themselves to be safer and more effective. This opinion stems from the fact that Multaq has been linked to liver failure and a worsening heart condition.
If you or a loved one has suffered from liver failure or a worsening heart condition after being treated with Multaq, contact the attorneys at Greg Jones today for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.