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