Almirall, S.A. (ALM:MC) and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the marketing approval for Constella ® (linaclotide 290 micrograms), for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
The CHMP positive opinion is a recommendation to the European Commission (EC) and one of the final steps in the review of a marketing authorization application. The EC usually follows the recommendations of the CHMP. Once approved, it will be marketed under the brand name Constella ® .
“Patients with IBS-C suffer from several very uncomfortable gastrointestinal symptoms for which there are currently very few available therapies”, said Bertil Lindmark, Chief Scientific Officer at Almirall. “With linaclotide physicians will have one of the first specifically designed therapies with proven efficacy and tolerability over time. Therefore, we are very pleased at Almirall with this first IBS-C treatment recommended for approval by CHMP and are confident in linaclotide’s benefits”.
This positive recommendation is based on the efficacy and safety of linaclotide evaluated in two double-blind, placebo-controlled Phase III clinical studies. The clinical trials involved approximately 1,600 adult patients, of which more than 800 were treated with linaclotide 290 mcg. In both trials, treatment with linaclotide resulted in statistically significant improvements in both abdominal pain/discomfort and degree of relief of IBS-C symptoms (co-primary endpoints), as well as complete spontaneous bowel movement frequency, stool consistency and severity of straining and bloating (secondary endpoints). These improvements were maintained over the entire treatment period (12 and 26 weeks). The incidence of adverse events was similar in both studies, with diarrhoea being the most common adverse event in linaclotide-treated patients i, ii.“This positive opinion is a significant step toward helping these highly symptomatic adult patients; many of whom are searching for new treatment options,” said Mark Currie, PhD, Senior Vice President, R&D and Chief Scientific Officer of Ironwood. “The discovery of linaclotide by Ironwood scientists and the work we have done to reach patients in Europe with our partner, Almirall, has been a collaborative effort with the goal of helping this underserved patient population.” Almirall holds exclusive marketing rights for linaclotide in Europe.