Portola Pharmaceuticals to file for FDA approval of the blood-thinning drug andexanet alfa in 2015
Thursday, April 09, 2015
Portola Pharmaceuticals Inc. took an important step toward its first drug approval with its experimental antidote for blood-thinning drugs passing a key clinical study, according to early results.
The South San Francisco-based company (NASDAQ: PTLA), led by CEO Bill Lis, said it would file for Food and Drug Administration approval of the drug, known as andexanet alfa, by the end of this year. Portola last year won the FDA's "breakthrough therapy" designation for the drug, which could accelerate its trip through the regulatory agency's approval process.
In Portola's study, andexanet alfa quickly reversed the blood-thinning effect of Bristol-Myers Squibb Co.'s (NYSE: BMY) Eliquis, the company said Wednesday. That is important when, for example, patients on so-called Factor Xa inhibitor blood thinners are rushed into surgery and need their blood to clot or when they have other "bleeding events".
Factor Xa inhibitors are a class of oral anticoagulants typically given to prevent or treat clots in a wide range of people, including those at risk of stroke or heart attack.
Andexanet alfa's effect could go beyond Eliquis, however. The company has set up andexanet alfa as a universal antidote for Factor Xa inhibitors. It also is testing its drug on Johnson & Johnson's rivaroxaban, known commercially as Xarelto, and Daiichi Sankyo's edoxaban, which still is in the clinic.
There are no other antidotes for Factor Xa inhibitors in development, the company said.
"These important findings show that andexanet alfa has the potential to treat a broad group of patients who require an antidote, including those requiring longer-duration reversal and those in which only short-duration reversal is necessary to address that patients' needs," said Dr. John Curnutte, Portola's executive vice president of research and development.
Portola stock gained 94 cents, up nearly 2.5 percent to $38.81 per share, in trading Wednesday.
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