Almirall files for EU approval of linaclotide for IBS-C

Almirall has submitted a European marketing authorisation application for linaclotide as a therapy for irritable bowel syndrome with constipation (IBS-C).

The application has been filed with the European Medicines Agency alongside phase III clinical trial data that demonstrates the safety and efficacy performance of the drug in two placebo-controlled trials and two long-term safety studies.

Linaclotide is an investigational guanylate cyclase-C therapy co-developed by Ironwood Pharmaceuticals and Forest Laboratories, with Almirall commercialising the drug in Europe.

If approved, it will be sold under the brand name Constella and will offer a new therapy option for a debilitating condition for which there are currently limited available treatments.

Bertil Lindmark, chief scientific officer at Almirall, said: "The results of clinical trials are extremely encouraging and, with this regulatory submission of linaclotide in IBS-C, we look forward to bringing this novel first-in-class medicine to patients in Europe."

Earlier this week, the company published data from a phase III trial of aclidinium bromide, a new therapy in development as a treatment for chronic obstructive pulmonary disease.