Portola caps a problem-plagued year with an application for anticoagulant betrixaban
Portola $PTLA has had an awful year so far in 2016. Its anticoagulant betrixaban failed a pivotal study in March and then the FDA rejected its closely-watched anti-anticoagulant Andexxa, designed to reverse anticoagulation for Factor Xa inhibitors. But as promised, the biotech is pushing ahead with an FDA application on betrixaban in any case.
The way their study was designed for betrixaban, investigators had to see a statistically significant advantage for their drug arm in a cohort of patients with elevated D-dimer levels—which is used to evaluate patients—in order to gain a clear understanding of the therapy’s benefit in a second cohort including older patients and then the entire patient population.
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