Baxter’s haemophilia drug performs
pharmafile | March 17, 2015 | News story | Sales and Marketing | BAX 817, VIIa, baxter, haemophilia, rFVIIa
Baxter International has reported positive Phase III clinical trial results for its investigational haemophilia drug BAX 817.
The recombinant factor VIIa (rFVIIa) treatment for people with haemophilia A or B who develop inhibitors – a molecule that binds to an enzyme and decreases its activity – was tested for its safety and efficacy in male patients ages 12 to 65.
The study met its primary endpoint with an overall success rate of 92%, 98% and 85% in each dosing group respectively. Furthermore, almost 90% of patients in the trial achieved sustained bleeding control for all acute bleeding episodes 24 hours after infusion.
“The development of inhibitors remains one of the most significant challenges in treating haemophilia, as it may place patients at increased risk for life-threatening complications resulting from difficult-to-treat bleeding episodes,” comments John Orloff, who is the vice president and global head of R&D at Baxter’s BioScience division.
He adds: “These positive results reflect our commitment to addressing the complex treatment of haemophilia patients with inhibitors, and reinforce our legacy of advancing haemophilia care worldwide.”
Haemophilia A is a rare condition which affects one in 10,000 males, according to The Haemophilia Society. B on the other hand affects around one in every 50,000, and only 20% of people with haemophilia have type B. There are approximately 6,000 people living with the condition in the UK.
Both types have the same symptoms but they are caused by problems with different clotting factors. Both are inherited conditions that affect the blood’s ability to clot – typically meaning someone with haemophilia will bleed for longer than usual.
US-based Baxter recently announced its plans to split into two independent firms. Later this year its BioScience division will branch out with a focus on addressing unmet medical needs in niche areas of oncology.
Moreover, Baxter’s medical products business will remain as it is, but with more of an effort on developing new healthcare solutions in hospital and home based therapies.
Full data from the BAX 817 trial, including additional efficacy and safety outcomes, will be presented at a medical meeting later in 2015.
Tom Robinson
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