Ipsen’s new carcinoid syndrome therapy accepted for EU regulatory review

Ipsen has announced that its telotristat etiprate therapy for the treatment of carcinoid syndrome caused by neuroendocrine tumours has been accepted for European regulatory review.

The European Medicines Agency has accepted the submission of a filing for telotristat etiprate as an adjunct to somatostatin analogue therapy for the long-term treatment of carcinoid syndrome to improve symptom control in adult patients with metastatic neuroendocrine tumours.

This submission was supported by the results of TELESTAR, a placebo-controlled phase III clinical trial and TELECAST, its phase III companion study. They showed that telotristat etiprate was able to reduce the average number of daily bowel movements and cut levels of urinary 5-hydroxyindoleacetic acid.

Ipsen is commercialising the drug in all territories worldwide other than the US and Japan, as part of a licensing agreement signed with Lexicon in October 2014.

David Meek, the new chief executive officer of Ipsen, said: "Ipsen is a global leader in neuroendocrine tumours and is committed to improve patient outcomes from diagnosis to each stage of the disease, including symptomatic treatment of carcinoid syndrome."

Mr Meek took over as chief executive of the company this week, succeeding Marc de Garidel, who now serves as non-executive chairman.