The U.S. Food and Drug Administration (FDA) has granted 510(k) marketing clearance to Shire’s myPKFiT for ADVATE, a free web-based software that is the first and only FDA-cleared pharmacokinetic (PK) dosing software for hemophilia A patients 16 and older weighing at least 45 kilograms treated with ADVATE.
Using as few as two measurable blood samples, myPKFiT for ADVATE generates a patient’s estimated individual PK profile to aid healthcare professionals in personalizing a patient’s prophylaxis ADVATE dose and schedule.
The myPKFiT for ADVATE software represents an innovative approach to estimating a patient’s PK curve, a key measure for assessing drug exposure over time. With myPKFiT for ADVATE, healthcare professionals can estimate a full PK curve with as few as two measurable blood samples, compared to 9 to 11 as recommended by guidelines from the International Society on Thrombosis and Haemostasis (ISTH). Using the patient’s PK curve and additional patient information, healthcare professionals can develop a personalized, PK-guided prophylactic ADVATE treatment regimen tailored to the individual patient’s needs.
“The FDA clearance of myPKFiT for ADVATE marks an important milestone in the personalization of hemophilia care, building on Shire’s strong commitment to continued innovation in hematology,” said Howard B. Mayer, M.D., ad-interim Global Head of Research and Development, Shire.
Hemophilia A, the most common type of hemophilia, is a rare bleeding disorder that causes longer-than-normal bleeding due to lack of clotting factor VIII in the blood. The severity of hemophilia A is determined by the amount of factor in the blood, with more severity associated with lower amounts of factor. More than half of patients with hemophilia A have the severe form of the condition. Hemophilia primarily affects males, with an incidence of one in 5,000 male births in the United States.
“We know patients have complex needs and treatment goals that cannot be met with a one-size-fits-all approach,” said Michael Denne, Head of U.S. Hematology Medical Affairs, Shire.
Version of the myPKFiT for ADVATE software has been CE marked in Europe since 2014.