The drug, BevyxXa, known also as betrixaban, is the first oral treatment and first extended duration treatment for this patient population, the company said.
Roughly 200,000 patients in the United States develop deep vein thrombosis each year and about 40,000 of these patients die of pulmonary embolism, caused when a blood clot breaks loose and travels to the lungs, blocking blood flow, the company said.
The drug does not currently face competition in the home setting, where the majority of DVT events occur, the company said.
Then it tested a lower risk group, and finally the overall patient population.
The FDA's analysis found the same thing.