Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) has been granted Breakthrough Therapy designation by the FDA in November for andexanet alfa (formerly PRT4445), its investigational Factor Xa inhibitor antidote.
The creation of this antidote is a big deal that can affect the lives of millions of people around the world.
A new generation of anticoagulants on the market, the so called Factor Xa inhibitors have shown substantial advantages over current standard therapies, such as the warfarin and enoxaparin.
However, physicians need a rapid reversal agent for patients who start bleeding or require urgent surgery. As it stands, no such antidote exists.
Although bleeding events occur infrequently (1-4 percent in clinical studies), the absolute number globally is really large due to...
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