Posted by Michael Wonder on 21 Jul 2017
Ipsen receives positive CHMP opinion for approval of Xermelo (telotristat ethyl), for the treatment of carcinoid syndrome diarrhoea in patients inadequately controlled by somatostatin analogue therapy
21 July 2017 - Positive opinion based on the results of two randomized Phase 3 trials, TELESTAR and TELECAST.
Ipsen today announced that the CHMP, the scientific committee of the EMA, has adopted a positive opinion recommending the approval of Xermelo (telotristat ethyl) 250 mg three times a day for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, as well as Norway, Liechtenstein and Iceland.
