FDA/CDC

FDA okays dosing software for hemophilia A


 

The Food and Drug Administration has granted 510(k) clearance to myPKFiT for ADVATE (Antihemophilic Factor, Recombinant), pharmokinetic dosing software used for tailoring prophylaxis regimens for hemophilia A patients.


The software can be used for hemophilia A patients aged 16 years or older who weigh at least 45 kilograms (about 99 pounds) and are treated with ADVATE.


The free, web-based software estimates a patient’s pharmokinetic curve using age, body weight, and local laboratory FVIII one-stage clotting activity measurements and allows physicians to estimate a full pharmokinetic curve with just two measurable blood samples, according to Shire, the software’s manufacturer. That’s much lower than the 9-11 blood samples recommendation from the International Society on Thrombosis and Haemostasis.

The software is expected to be available in the United States by the end of the first quarter of 2018. A version of the software is already marketed in Europe.

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