The US Food and Drug Administration has granted priority review designation for combination pill LCZ696 (valsartan and sacubitril), an investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF), from Swiss pharma giant Novartis (NOVN: VX).
The designation accelerates the review of therapies thatoffer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. For LCZ696 this reduces the total review time from 12 to eight months, meaning the FDA could make a decision on approval in August 2015.
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
7 day trial access
Become a subscriber
Or £77 per month
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
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze