FDA Approves Portola Drug Betrixaban For Blood Clot Prevention
A new blood-thinning drug manufactured by Portola Pharmaceuticals has received approval for blood clot prevention from the United States Food and Drug Administration on Friday, June 23.
Bevyxxa, which is also known as betrixaban, is an oral treatment designed for hospitalized acutely ill patients who will not receive surgery. The drug, which is the first extended duration treatment for this patient population, prevents pulmonary embolisms and deep vein thrombosis.
Deadly Blood Clotting
Approximately 200,000 people in the United States develop deep vein thrombosis every year, with roughly 40,000 patients dying of pulmonary embolisms or the blockage of a major blood vessel in the lungs due to blood clotting.
The approval of betrixaban was based on the phase 3 APEX study, which was a double-blind, randomized, and multinational clinical trial that compared betrixaban to enoxaparin. Betrixaban was given to patients for 35 to 42 days, while enoxaparin was given for a period of six to 14 days to 7,513 patients.
Patients in the betrixaban group received an initial dose of 160 milligrams on day 1 and was followed by 80 milligrams once every day for the next 35 to 42 days. They were also injected with placebo once daily for six to 14 days.
Meanwhile, patients in the enoxaparin group were given an initial dose of 40 milligrams that was injected for six to 14 days and then took an oral placebo for 35 to 42 days.
Few pulmonary embolism-related deaths were recorded among patients who received betrixaban at a rate of 4.4 percent. On the other hand, the relative risk of pulmonary embolism-related deaths among patients who received enoxaparin was at 6 percent.
Side Effects Of Betrixaban And Enoxaparin
The most common side effects of betrixaban were related to bleeding. Study authors note that 54 percent of patients who received betrixaban experienced at least one side effect, while 52 percent of patients who received enoxaparin did so.
There was also no difference in the frequency of patients who reported serious adverse reactions for both betrixaban and enoxaparin, at 18 percent and 17 percent respectively.
Furthermore, the most common reason for discontinuing the betrixaban or enoxaparin treatment was bleeding, with a rate of 2.4 percent for betrixaban and 1.2 percent for enoxaparin.
C. Michael Gibson, one of the APEX study investigators, believes betrixaban is a major advancement in the treatment of deep vein thrombosis.
"It is the first therapy to demonstrate a reduction in the incidence of VTE in these high-risk patients without a significant increase in major bleeding," said Gibson.
News of betrixaban's FDA approval prompted Portola's shares to increase by as much as 51 percent to $57.90. Analysts expect betrixaban to generate sales of $313 million by 2020 and that it will rise $1 billion by 2023. Porta will launch Bevyxxa between August and November.