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
Attigo (part of the Mednet Group)

Inclusion drives innovation. Attigo, a social enterprise, helps pharma and the socially conscious business shape the future by engaging with...

Latest intelligence

What challenges still face clinical trial recruitment and retention?
Discover the reasons for the current clinical trial recruitment challenges facing pharma and the life sciences industry, and how the search for solutions to the problem continues...
“Fake News” and Credibility in Medical Publishing
Natalie Yeadon from Impetus Digital shares her thoughts on fighting fake news in Pharma and healthcare....
Delivering true value: what does it mean for KAM in cancer care?
Lisa Alderson, Business Development Director at Wilmington Healthcare, explores the challenges that pharma’s KAM teams face in engaging with the NHS and how they must evolve...

Infographics