Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, announced that the European Commission(EC) has approved Xermelo® (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy. This approval allows for the marketing of Xermelo® (telotristat ethyl) in the above indication in all 28 member states of the European Union(EU), Norway and Iceland.

David Meek, Chief Executive Officer, Ipsen stated: “We are delighted to provide patients suffering from inadequately controlled carcinoid syndrome with a new treatment option in combination with a somatostatin analogue that demonstrates both efficacy and safety in particularly improving diarrhea, a most debilitating symptom. Xermelo® complements our strategy for neuroendocrine tumors aiming to deliver clinical benefits along every step of the patient treatment journey.”

 “As a physician involved in the management of patients living with carcinoid syndrome, I am encouraged by the European approval of Xermelo® as a new therapeutic option for this difficult-to-treat condition” said Professor Dieter Hörsch MD PhD, ENETS Center of Excellence for Neuroendocrine Tumors in Bad Berka, Germany. He added: “Thanks to our experience with Xermelo® in clinical trials we observed profound improvement of quality of life and well-being of our patients. The positive safety and efficacy data prompted its rapid integration in clinical practice guidelines.”

According to Teodora Kolarova, Executive Director of the International Neuroendocrine Cancer Alliance (INCA)[1] “The severe and unpredictable diarrhea associated with carcinoid syndrome has significant negative impact on patients’ lives. The majority of patients affected by this  condition see it interfere severely with their physical and emotional health, social role and lifestyle. Access to new treatments, more information and support is warranted.”

The approval is based on the results of two randomized Phase 3 trials, TELESTAR and TELECAST.