A panel of FDA advisers voted in favor of approving Daiichi Sankyo's irregular heartbeat treatment edoxaban, heralding its ability to break up blood clots and improving the company's odds of finally launching the drug in the U.S.
Daiichi Sankyo's pill is a once-a-day treatment that works by blocking Factor Xa, a protein that helps blood coagulate. On Thursday, the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9-1 that edoxaban's benefits outweigh its risks in preventing strokes among patients with atrial fibrillation, a cardiac arrhythmia.
But it wasn't a clean sweep. Three of the panelists recommended approving Daiichi Sankyo's drug only in patients with kidney problems, pointing to Phase III data in which edoxaban soundly beat out the anticoagulant warfarin in subjects with impaired kidney function but failed to do so in those without.
The majority, however, sided with Daiichi Sankyo, and the FDA, while not beholden to following the votes of its advisers, commonly does just that. The agency is expected to hand down a final decision by Jan. 8.
If the drug, to be marketed as Savaysa, wins full approval, it'll face a host of next-generation anticoagulants. The top competitor for Daiichi Sankyo's drug would likely be Bayer and Johnson & Johnson's ($JNJ) Xarelto, a once-daily pill, followed by twice-a-day treatments Eliquis, from Bristol-Myers Squibb ($BMY) and Pfizer ($PFE); and Pradaxa, made by Boehringer Ingelheim. Analysts expect the market for such warfarin alternatives to reach as high as $10 billion a year.
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