The approval comes with a Risk Evaluation and Mitigation Strategy (REMS), required by the FDA to ensure that the drug’s benefits drug outweigh its risks, which includes a patient medication guide describing the risks of the drug to be distributed to patients with each filled prescription.
Apixaban should be "widely available" in the United States by the end of January 2013, according to a statement issued by BMS on Jan. 2.
The wholesale acquisition cost for apixaban is $8.35 per day, for both doses, according to a spokesperson for Pfizer.
Dr. Kaul said he had no disclosures relevant to apixaban. He is a stockholder in Johnson & Johnson, a cosponsor for rivaroxaban, and sat on the FDA advisory committees that reviewed dabigatran and rivaroxaban. There was no advisory panel meeting on apixaban.
Dr. Bhatt said that he has received research grants from BMS, and has served on the steering committee of APPRAISE-2 (apixaban studied in acute coronary syndromes). His other disclosures include being a member of the clinical trial steering committees of the Duke Clinical Research Institute.
The prescribing information is available here. The patient medication guide is available at the FDA.
Serious adverse events associated with apixaban should be reported to the FDA’s MedWatch program or at 800-332-1088.