Constipation new drug Linzess Japan III success, China is expected to be listed in 2016
December 04, 2015 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Ironwood Pharmaceuticals and its partner, Astellas, announced the treatment of constipation-type bowel in the gastrointestinal dysfunction drug linaclotide (linalotide, US brand name: Linzess, European brand name: Constella) A phase III study of adult patients with irritable bowel syndrome (IBS-C) reached the primary end point. Astellas has planned to submit a new drug application for linaclotide to the Japanese Ministry of Health, Labor and Welfare (MHLW) in 2016.
The study was a randomized, double-blind, placebo-controlled phase III study (n=500) performed in adults with constipation-type irritable bowel syndrome (IBS-C) in Japan, investigating the efficacy and safety of linaclotide.
The data showed a statistically significant improvement in the linaclotide (500 microgram dose) treatment group at the two common primary endpoints of the study compared to the placebo group.
In the first endpoint, a higher proportion of patients in the linaclotide group had an improvement in IBS symptoms compared with placebo (34% vs 18%, p < 0.001).
In the second endpoint, a higher proportion of patients in the linaclotide-treated group were complete spontaneous spontaneous defecation (CSBM) responders (35% vs 19%, p < 0.001) compared with the placebo group.
In addition, the linaclotide treatment group showed improvement in pre-specified secondary endpoints (abdominal and constipation symptoms, including bloating, abdominal pain/discomfort). In the study, the diarrhea rate was higher in the linaclotide group than in the placebo group (9.6% vs 0.4%), and the severity of all cases was mild or moderate.
The Phase III study also included an additional 40-week open-label follow-up period, currently in progress. Linaclotide was developed by Ironwood, which signed a licensing agreement with Astellas to develop and commercialize linaclotide in Japan. Astellas has planned to submit a listing application for linaclotide to Japanese regulators in 2016.
Currently, linaclotide has been approved by the US FDA for the treatment of adult patients with chronic idiopathic constipation (CIC) and constipation-type irritable bowel syndrome (IBS-C). In the US and European markets, linaclotide is marketed jointly by Ironwood and Allergan.
It is worth mentioning that British pharmaceutical giant AstraZeneca (AZN) has cooperated with Ironwood in 2012 to jointly develop and commercialize linaclotide in China. Both parties hope to take this opportunity to bring linaclotide into a huge and growing pole. Fast Chinese market to get bigger profits. In July of this year, a Phase III IBS-C study in China reached all major and minor endpoints. Both parties have planned to submit a listing application to the China Food and Drug Administration (CFDA) in 2016. If approved, linaclotide (brand name: Linzess) will be the first prescription drug for the treatment of IBS-C patients in the Chinese market. It is estimated that there are about 13 million IBS-C patients in China, and the Chinese market is much larger than other countries.
Source: Astellas and Ironwood Report Positive Top-Line Data from Phase III IBS-C Trial Conducted in Japan
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