MyPKFiT for Advate is the first and only pharmacokinetic (PK) dosing software approved by the U.S. Food and Drug Administration (FDA) for use in hemophilia A.
myPKFiT helps healthcare professionals create personalized regimens of Advate dose and schedule in patients aged 16 and older who weigh more than 100 pounds (45 kilograms).
“A version of myPKFiT has already been widely adopted in Europe since 2014, and we’ve seen how important it has been in helping physicians develop personalized dosing regimens tailored to the specific needs of their patients,” said Andreas Busch, global head of research and development at Shire, in a press release. “As part of our commitment to precision medicine, we are pleased to bring this innovative application to physicians and patients in the United States.”
Advate is a full-length (derived from the complete FVIII gene) recombinant factor VIII product that is processed without any blood-based additives. The recombinant anti-hemophilic factor is indicated for use in children and adults with hemophilia A for the control and prevention of bleeding episodes, perioperative management and routine prophylaxis (prevention) therapy.
The myPKFiT software is innovative in the way it estimates a patient’s PK curve, a key measure for assessing drug exposure over time. Now, healthcare professionals can estimate a full PK curve with as few as two measurable blood samples, much less than the nine to 11 recommended by the ISTH guidelines.
“We understand that people with hemophilia have their own treatment goals, needs and challenges that require a customized approach to care,” said Michael Tarantino, MD, president of the Bleeding and Clotting Disorders Institute. “The myPKFiT software enables healthcare professionals to gain an even clearer picture of their patients’ treatment needs to develop an Advate prophylaxis dose and schedule that’s truly tailored to each individual patient.”
MyPKFiT received FDA clearance in January.
In the U.S., hemophilia is estimated to affect one in 5,000 male births. More than half of all patients eventually develop a severe form of the disease. More than 50 percent of hemophilia A patients have the severe form of the condition.