Positive Phase III results for Astellas and Ironwood's Japan trial of linaclotide
Japanese drug major Astellas Pharma (TYO: 4503) and the USA’s Ironwood Pharmaceuticals (Nasdaq: IRWD) say that the Phase III clinical trial of linaclotide conducted in Japan in adults with irritable bowel syndrome with constipation (IBS-C) met its primary endpoints.
Astellas noted that it now expects to submit a new drug application to the Ministry of Health, Labor and Welfare in Japan in 2016.
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist currently approved in the USA for the treatment of adults with IBS-C and chronic idiopathic constipation (CIC). It is also approved for adults with IBS-C or CIC in more than 30 other countries.
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