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.”
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.”