Please login to the form below

Not currently logged in
Email:
Password:

Digital intelligence blog

Pharma insight on digital marketing, social media, mobile apps, online video, websites and interactive healthcare tools

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

Share

Tags

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Nucleus Global

Nucleus Global is the largest specialist medical communications network in the world. Globally, we have over 800 experts delivering world-class...

Latest intelligence

How innovating study sites can improve patient recruitment efficiency
There are so many ways that clinical trials have innovated over the last few years. There is now a larger focus on making trials more patient-centric, more virtualised, and more...
PME-MAY21-Cover
Avoiding A Series of Unfortunate Events: launch lessons from lockdown
Chris Ross takes a novel look at launch excellence through the lens of COVID-19 and explores how pharma’s launch leaders are rewriting the story...
6 reasons patients drop out of clinical trials and 6 ways to fix it
If you’ve successfully recruited patients for your clinical trial, but one by one, they begin to drop out, then this information could be for you....