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.
That didn’t happen (the p-value was a near miss at 0.054), but the researchers went on to do an “exploratory” analysis of the data that they claim showed a reduced risk for venous thromboembolism in the betrixaban arm when compared with enoxaparin.
Company representatives have insisted to me that the analysis qualifies this study as a success, but that will have to be up to the FDA now, as well as a likely panel of experts, if the agency accepts the application as filed.
John Curnutte, Portola’s EVP for research, said:
“If approved, betrixaban would be the first anticoagulant indicated for the prevention of VTE in acute medically ill patients both during hospitalization and for an extended period after the patient returns home.”
The FDA has 60 days now to decide whether or not it will review the application.
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