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Bristol-Myers Squibb and Pfizer announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial therapy.

The summary below gives an overview of important additions and changes MPR has made to its drug database through the end of April. The chart below provides highlights of key monograph updates made this month (not an inclusive list).

New recommendations have been developed for the optimum management of atrial fibrillation.

Bristol-Myers Squibb and Pfizer announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial that assessed the effect of blood pressure control on outcomes as well as the treatment effect of Eliquis (apixaban) vs. warfarin to blood pressure control in patients with nonvalvular atrial fibrillation (NVAF).

Bristol-Myers Squibb and Pfizer announced that the FDA has approved a sNDA for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients who have undergone hip or knee replacement surgery.

Most people with nonvalvular atrial fibrillation (NVAF) should be taking oral anticoagulants to prevent stroke.

Bristol-Myers Squibb and Pfizer announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial according to patient age in patients with nonvalvular atrial fibrillation (NVAF).

The FDA has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis (apixaban; Bristol-Myers Squibb Company and Pfizer) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE.

Patients taking the new generation of oral anticoagulants appear to have a higher risk of gastrointestinal bleeding compared with standard care.

The FDA has accepted Bristol-Myers Squibb’s and Pfizer’s supplemental New Drug Application for Eliquis (apixaban), an oral direct Factor Xa inhibitor for prophylaxis of deep vein thrombosis (DVT) following hip or knee replacement surgery.