Ironwood Pharmaceuticals’ Linzess (linaclotide) Receives the US FDA’s Approval for the Treatment of Functional Constipation in Pediatric Patients Aged 6-17 Years
Shots:
- The US FDA has approved Linzess (qd) for pediatric patients aged 6-17yrs. with functional constipation. Linzess is being developed & marketed by AbbVie & Ironwood in the US
- The approval was based on the P-III study evaluating Linzess (72mcg) vs PBO in a ratio (1:1) in 328 patients aged 6-17yrs. which showed a clinical improvement over PBO in 12wk. spontaneous bowel movement (SBM) frequency rate (SBMs/week)
- The results also showed a greater than two-fold least squares mean change from baseline in SBMs/week (2.6 vs 1.3). Ironwood also collaborated with AstraZeneca to develop & commercialize Linzess in China & with AbbVie for the development & commercialization of linaclotide in all other territories globally
Ref: Businesswire | Image: Ironwood
Related News:- Ironwood Pharmaceuticals' Linzess (linaclotide) Receives NMPA (CMPA) Approval for Irritable Bowel Syndrome with Constipation (IBS-C)
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