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news.Baxter International has reported that the FDA has approved Ceprotin, a blood clotting agent for use as replacement therapy in patients with life-threatening complications related to severe congenital Protein C deficiency.
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Severe congenital Protein C deficiency results in a hypercoagulable state, meaning there is an abnormal tendency for blood clotting. This can cause severe, often life-threatening blood clots in small blood vessels, which if left untreated could result in blindness, severe brain damage, multi-organ failure and death.
Currently, there are fewer than 20 known cases of severe congenital Protein C deficiency in the US. FDA has granted Ceprotin orphan drug status. Ceprotin is the first FDA approved therapy for patients with severe congenital Protein C deficiency.
Ceprotin’s approval is based on data from a phase II/III study, which evaluated the safety and efficacy of Ceprotin in subjects with severe congenital Protein C deficiency for the treatment of acute thrombotic episodes, such as purpura fulminans (PF), warfarin-induced skin necrosis (WISN), and other thromboembolic events, and for short-term or long-term prophylaxis. Ceprotin was demonstrated to be effective in 94% of the episodes of PF.