A Food and Drug Administration advisory committee has recommended that the agency approve a new drug to prevent deep vein thrombosis and pulmonary embolism in patients after hip- or knee-replacement surgery.
If approved, rivaroxaban, a joint venture between Bayer Healthcare Pharmaceuticals and Johnson & Johnson, would be the first major competitor to warfarin, which has been the dominant oral anticoagulant to treat thrombosis on the market. Johnson & Johnson is initially only seeking approval to market rivaroxaban for short-term use after orthopedic surgery, but industry analysts say the medication’s applications may expand in the future.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 15-2 to recommend approval of the drug. The New York Times reports that the agency typically goes with the recommendations of its advisory panels, but notes that "the review of rivaroxaban was not without contention." Twenty-four patients who took rivaroxaban pills in the clinical trials experienced major bleeding, compared with 13 who had injections of a different anticoagulant drug, enoxaparin.
—Irene Tsikitas
