Chinese nod for IBS drug linaclotideMarch 7, 2019
I ronwood Pharmaceuticals, Inc has received marketing authorisation from the National Medical Products Administration (NMPA) for linaclotide (Linzess) in China for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C).
Linaclotide is a guanylate cyclase-C (GC-C) receptor agonist. The drug binds to the GC-C receptor locally, within the intestinal epithelium. Activation of the GC-C results in increased intestinal fluid secretion accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine.
The NMPA approval is based on a phase III global, multicentre, clinical trial, jointly conducted by AstraZeneca China and Ironwood, in five countries, which evaluated the efficacy and safety of Linzess in patients with IBS-C.
Launch of linaclotide in China is expected in the second half of 2019.