Positive results for AstraZeneca and Ironwood linaclotide will support approval in China

8 July 2015

Anglo-Swedish pharma major AstraZeneca (LSE: AZN) and USA-based Ironwood Pharmaceuticals (Nasdaq: IRWD) say that top-line data demonstrate linaclotide met all primary and secondary endpoints, covering multiple abdominal and constipation symptoms, in a Phase III clinical trial of adults with irritable bowel syndrome with constipation (IBS-C).

The trial was conducted primarily in China and the companies intend to file in early 2016 for China Food and Drug Administration (CFDA) approval to market linaclotide. Linaclotide is currently approved in the USA, where it is sold as Linzess, for the treatment of adults with IBS-C or chronic idiopathic constipation (CIC) and in a number of other countries for adults with IBS-C.

Linaclotide would be first IBS-C treatment for male and female adults

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 account

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

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical