Ironwood Pharmaceuticals' Linzess (linaclotide) Receives NMPA (CMPA) Approval for Irritable Bowel Syndrome with Constipation (IBS-C)
Shots:
- The approval is based on P-III study results assessing Linzess (290 mcg) vs PBO in 839 patients in ratio the (1:1) with IBS-C in adults for 12 weeks
- The P-III study demonstrated 1EP & 2EP as Abdominal Pain/Discomfort Responders (60% vs 48.8%) & IBS Degree of Relief Responders (31.7% vs 15.4%) respectively
- Linaclotide is guanylate cyclase-C (GC-C) agonist that binds to GC-C receptor- approved in 30 countries including the US for IBS-C and is developed in collaboration with AstraZeneca with its expected launch in H2’19
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