Ironwood Pharmaceuticals Inc.'s Linzess was approved in China to treat adults with a certain digestive system disorder.
China's National Medical Products Administration granted the marketing authorization to Linzess, or linaclotide, to treat irritable bowel syndrome with constipation, or IBS-C.
Irritable bowel syndrome is a common condition that affects the digestive system and can cause symptoms like stomach cramps, abdominal pain, bloating, and diarrhea or constipation, or both. About 14 million adults in China suffer from IBS-C, Cambridge, Mass.-based Ironwood said in a Jan. 15 news release.
The approval in China follows positive results from a phase 3 trial in the country, which showed that patients treated with the drug had significant improvement in abdominal pain and discomfort versus placebo and also saw greater relief in their symptoms compared to the patients on placebo.
In addition, patients in the Linzess group also saw improvements in bloating, straining, the frequency of complete spontaneous bowel movements, the frequency of spontaneous bowel movements and stool consistency.
Ironwood and British biopharmaceutical company AstraZeneca PLC are jointly developing and commercializing linaclotide in China, with AstraZeneca primarily responsible for local operational execution. The companies expect to launch the drug in China in the second half of 2019.
Linzess is marketed in Europe by Allergan PLC as Constella. The drug is also approved for IBS-C or chronic idiopathic constipation, or chronic constipation, in the U.S. and over 30 other countries.