US priority review for Boehringer’s Pradaxa antidote
The US Food and Drug Administration has granted Priority Review to German family-owned drug major Boehringer Ingelheim’s Biologics License Application (BLA) for idarucizumab, which is being investigated to specifically reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa (dabigatran etexilate mesylate) in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event.
The idarucizumab BLA, which was submitted last month (The Pharma Letter March 2), will be reviewed under accelerated approval and is the first review for a reversal agent in the novel oral anticoagulant (NOAC) class. Currently, no NOACs have an approved reversal agent. Pradaxa generated sales of 1.20 billion euros ($1.29 billion) for the company in 2014. Idarucizumab received Breakthrough Therapy designation from the FDA last year (TPL June 26, 2014).
New innovative option in anticoagulation care
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.
Login to your accountTry before you buy
Free
7 day trial access
- 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
- 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
Today's issue
Company Spotlight
More Features in Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze