Ironwood gains 1st FDA OK with IBS-C/CIC drug; investors unimpressed
This article was originally published in Scrip
Executive Summary
Ironwood Pharmaceuticals and Forest Laboratories on 30 August won the US FDA's endorsement to market Linzess (linaclotide) as a once-daily treatment for irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), with the approval coming several days ahead of the expected action date, although regulators had taken an extra few months in their review of the drug's application.