Fewer Doses for Hemophilia A Patients May Be Possible
A new drug may be able to extend protection for a week or longer.
Last Monday, June 12, the biotech firm Bioverativ announced that its new hemophilia treatment had been accepted by the U.S. Food and Drug Administration (FDA) as an investigational new drug (IND). The medication, currently called BIVV001 and also known as rFVIIIFc-VWF-XTEN, is an investigational factor VIII therapy that may be able to extend protection from bleeds with prophylaxis dosing of once weekly or less for people with hemophilia A.
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According to the news release, BIVV001 is the only investigational factor VIII therapy in development that is designed to overcome the von Willebrand factor ceiling, which is believed to impose a half-life limitation on current factor VIII therapies. “BIVV001 is the first molecule of its kind to fuse four different proteins together to address the challenges of hemophilia A,” said Rob Peters, PhD, senior vice president of research at Bioverativ. “We are encouraged by our extensive preclinical data, which show improved pharmacokinetics that are independent of von Willebrand factor.”
The FDA’s acceptance of Bioverativ’s IND application opens the door for additional testing of the drugs’ safety and efficacy. A Phase ½a clinical trial is expected to begin later this year.
Hopefully, the results will be positive, which will be great news for those with hemophilia A, who could have fewer injections if BIVV001 makes it to market. Of course, you’ll need to monitor patient outcomes to verify the drug’s efficacy for each of your patients. CareTend, the latest home infusion software solution from Mediware, with secure management of all your patient data, can help.