Takeda unveil new Adynovate data at ISTH 2019

9 July 2019

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) announced updated results from its Phase IIIb/IV clinical trial for Adynovate (antihemophilic factor [recombinant], PEGylated) at the 27th Annual International Society on Thrombosis and Hemostasis Congress (ISTH), in Melbourne, Australia.

The PROPEL study is a PROspective, randomized, multi-center study comparing the safety and efficacy of Adynovate following PK-guided prophylaxis targeting two different Factor Eight (FVIII) trough activity Levels in subjects with severe hemophilia A.

The latest results of the landmark PROPEL study show that Adynovate prophylaxis in severe hemophilia A patients may enhance a patient’s PK profile - by targeting FVIII trough levels of 8%–12% (elevated prophylaxis arm, ELE) as compared with 1%–3% (reference prophylaxis arm, REF). This represents a clinically-meaningful trend towards more patients experiencing zero bleeds [62% ELE versus 42% REF, respectively; p=0.0545].Patients randomized to the 8%-12% target group also saw a:

Reduced mean total annualized bleed rate (ABR); (1.6 ELE versus 3.6 REF, respectively).
Reduced mean spontaneous joint ABR (0.5 ELE versus 2.0 REF)

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK