Irish biotechnology firm Shire has received 510(k) marketing clearance for its myPKFiT for ADVATE [Antihemophilic Factor (Recombinant)] software from the US Food and Drug Administration (FDA).
myPKFiT for ADVATE is designed as a web-based pharmacokinetic (PK) dosing software for haemophilia A patients aged 16 and above who weigh a minimum 45kg and have been treated with ADVATE.
Approved in 69 countries, ADVATE is a full-length recombinant FVIII product processed without blood-based additives.
myPKFiT for ADVATE allows development of a personalised, PK-guided ADVATE treatment regimen customised to the individual needs of patients.
The software uses age, body weight information, and local laboratory FVIII one-stage clotting activity measurements to generate ADVATE dosage and frequency recommendations for routine prophylaxis.
Shire Research and Development ad-interim global head Howard Mayer said: “The FDA clearance of myPKFiT for ADVATE marks an important milestone in the personalisation of haemophilia care, building on Shire’s strong commitment to continued innovation in haematology.”
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Output from the software can be used to guide decisions on appropriate dose and infusion intervals to maintain FVIII activity levels that are compliant with the FDA-approved dosing recommendations.
Shire US Haematology Medical Affairs head Michael Denne said: “We know patients have complex needs and treatment goals that cannot be met with a one-size-fits-all approach.
“myPKFiT for ADVATE offers a personalised approach to haemophilia care that allows healthcare professionals to consider their patients’ individual needs and to educate them on their personal PK profiles.”