Shire Korea said Monday that the Ministry of Food and Drug Safety has approved myPKFiT 3.0, a web-based personalized medical device for hemophilia patients.
The new product is a medical device that can simulate the dose setting of Shire’s two hemophilia preventive therapies -- Advate and Adynovate -- considering the characteristics of each patient with hemophilia A using the two drugs.
The device allows clinicians to take two blood samples from hemophilia A patients taking Advate or Adynovate to identify pharmacokinetic results and develop personalized treatment plans. Its prior 2.0 version received approval in Korea in November 2017.
“Pharmacokinetic profiles, joint status, and treatment goals are different for each hemophilia patient, and a patient-tailored treatment strategy that considers these factors is important,” the company said. “Also, since each hemophilia patient has different physical characteristics and lifestyle, such as age and weight, there are many things to consider in establishing a preventive treatment plan.”
Compared to the existing 2.0 version, the most noticeable change in the 3.0 version is that hospitals can also use the device on patients mainly treated with Adynovate.
Also, the previous version provided only the amount of coagulation factor that can maintain the level of coagulation factor when patients put in the desired level of the coagulation factor. In the 3.0 version, however, patients can put in their schedule and dosage of coagulation factors, and the application function will estimate the FVlll value of Advate or Adynovate in real time as well as setting the dosage schedule on a weekly basis.
“There are many considerations for establishing a preventive therapies plan for hemophilia patients,” said Kim Na-kyung, vice president of Shire Korea’s hematology division. “Our myPKFiT 3.0 simulates the pharmacokinetic profile of patients receiving Advate or Adynovate more easily and helps to determine the optimal dosing cycle for each patient.”