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Shire wins FDA approval for haemophilia dosing software

The web-based myPKFiT supports the pharma firm's Advate treatment

US Food and Drug Administration (FDA)

US regulators have approved Shire’s new web-based dosing software for its recombinant Factor VIII haemophilia A treatment Advate.

Healthcare professionals in the country will soon be able to use myPKFiT to create personalised dosing regimens for patients aged 16 or over following the FDA’s decision.

Using at least two blood samples, myPKFiT generates a patient’s estimated pharmacokinetic (PK) profile to help healthcare professionals personalise a dose of Advate.

Shire said it expected to launch the software in the US before April, and it hopes to speed up a process that currently can require up to 11 blood samples.

Howard Mayer, ad-interim global head of research and development at Shire, 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.”

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

16th January 2018

From: Marketing

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