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Less than a month after seeking European approval for linaclotide, Ironwood Pharmaceuticals Inc. has learned the U.S. Food and Drug Administration has accepted for review its New Drug Application for the drug candidate to treat irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC).
Linaclotide, developed with partner Forest Laboratories Inc. (NYSE: FRX) of New York, submitted its NDA for linaclotide in August. Both the European and U.S. approval application submissions were based on encouraging clinical trials. The two companies reported positive results last November in a second Phase 3 clinical trial for both efficacy and safety. The first Phase 3 trial also landed positive results, giving Ironwood and Forest a pool of 2,800 patients who participated in four trials testing for IBS-C and CC, as well as 3,200 patients participating in current open-label safety trials. According to a news release from the two companies, more than 2,000 of the open-label safety trial patients have been taking linaclotide for at least one year.
If approved, linaclotide will be co-promoted by both Cambridge-based Ironwood and Forest. Ironwood noted its European development and commercialization has been licensed out to Almirall SA, and Astellas Pharma Inc. has secured licensing rights for development and commercialization in Japan, Indonesia, Korea, the Philippines, Taiwan and Thailand.
In January, CEO Peter Hecht told Mass High Tech that the company plans to focus on linaclotide for the next few years. “There’s an enormous effort to submit the highest quality regulatory documents in the shortest amount of time,” he said at the time.
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