Shire's Lialda now OKed for ulcerative colitis maintenance of remission in the USA
The US Food and Drug Administration has approved Ireland-headquartered specialty drugmaker Shire’s (LSE: SHP) Lialda (mesalamine) delayed-release tablets for the maintenance of remission in patients with ulcerative colitis.
This approval is based on results from a six-month study demonstrating the safety and effectiveness of Lialda in maintaining endoscopic remission in adult patients. This follows the previous indication of Lialda approved by the FDA in 2007 for the induction of remission in patients with active, mild-to-moderate ulcerative colitis. Lialda, also sold as Mezavant, last year achieved sales of $293 million, up 24% on the previous year.
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
| Headless Content Management with Blaze