AndexXa was developed to induce blood clotting in patients with life-threatening or uncontrolled bleeding.
The drug is tailored towards individuals being treated with anticoagulant. According to Portola, there is no FDA-approved blood thinner antidote available for this patient population.
The FDA requested additional information regarding the manufacturing and marketing of the drug before granting approval.
Portola’s shares fell 11 percent to $23.69 on Wednesday in response to news of the drug’s rejection.
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