FDA clears myPKFiT for ADVATE to help personalize care for hemophilia A

First and only FDA-cleared PK dosing software to support healthcare professionals in creating personalized dosing regimens for patients 16 and older with hemophilia A.

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 with 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, ad-interim Global Head of R&D, Shire.

"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 US Hematology Medical Affairs, Shire. "myPKFiT for ADVATE offers a personalized approach to hemophilia care that allows healthcare professionals to consider their patients' individual needs and to educate them on their personal PK profiles."

A version of the myPKFiT for ADVATE software has been CE marked in Europe since 2014.