Late-stage Pfizer drug study shows significant reduction in haemophilia B bleeding

pharmafile | March 9, 2016 | News story | Research and Development BeneFIX, Pfizer, haemophilia B 

Pfizer on Wednesday said late-stage trials for its drug candidate to treat haemophilia B showed prophylactic use resulted in significant reduction in bleeding compared with on-demand therapy.

Pablo Rendo, global clinical lead, senior director, physician clinicians at Pfizer, comments: “In this study, a once-weekly prophylactic regimen with BeneFIX (recombinant) provided a significant reduction in bleeding, which is an important goal in managing haemophilia.”

The company said Phase III study was for once-week regimen of BeneFIX for moderately severe or severe haemophilia B.

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The findings were published in Haemophilia, the official journal of the World Federation of haemophilia.

Haemophilia is a type of bleeding disorder that causes the blood to take a long time to clot as a result of a deficiency in one of several blood clotting factors, and occurs almost exclusively in males. People with haemophilia B have a deficiency in clotting factor IX, a specific protein in the blood.

BeneFIX received first approval in the United States in 1997. In the US, BeneFIX is indicated for the control and prevention of bleeding episodes in adult and paediatric patients with haemophilia B, including perioperative management. It is not approved there for prophylactic use.

The drug is approved in Europe for treatment and prophylaxis of bleeding in patients with haemophilia B.

Anjali Shukla

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