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
Mind+Matter

We are Mind ‘PLUS’ Matter. The ‘plus’ is important to us because we are all about offering more for our...

Latest intelligence

Food Allergy – Is avoidance the only option?
Following on from Allergy Awareness Week 2022, we’re continuing the discussion about food allergies and the experiences of those who live with them. In this blog, we discuss the current...
Serious about sustainability?
Get to know our new Sustainability Officer here at Cuttsy+Cuttsy...
How scientific storytelling can help Pharma cut through the noise
Rather than being afraid of storytelling, pharmaceutical firms should be embracing it. Because what scientific storytelling allows us to do is to communicate quickly and efficiently. It provides a shortcut...