16 October 2018 - Xermelo is a first-in-class treatment option for patients whose refractory carcinoid syndrome diarrhoea is inadequately controlled with somatostatin analogue therapy alone.

Ipsen Biopharmaceuticals Canada announced today Health Canada's approval of Xermelo (telotristat ethyl) for the treatment of refractory carcinoid syndrome diarrhoea, in combination with somatostatin analogue (SSA) therapy, in patients inadequately controlled by SSA therapy alone.

Xermelo is a novel, orally administered, inhibitor of the enzyme tryptophan hydroxylase and is designed to reduce the production of serotonin. The approval was based on the positive results of the TELESTAR pivotal trial and the TELECAST trial, two phase 3, randomised, placebo-controlled, 12-week trials where the efficacy and the safety of Xermelo were demonstrated in carcinoid syndrome patients. Both trials reported statistically significant reductions of bowel movement frequency compared with placebo and change in u5-HIAA from baseline.

Read Ipsen press release