European Commission has approved Xermelo (telotristat ethyl) 250 mg as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog therapy.- Ipsen + Lexicon Pharmaceuticals.
Lexicon Pharmaceuticals, Inc. announced that the European Commission has approved Xermelo (telotristat ethyl) 250 mg as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. This approval allows for the marketing of Xermelo by Lexicon’s collaborator, Ipsen, in the above indication in all 28 member states of the European Union, Norway and Iceland.
Carcinoid syndrome is a rare and debilitating condition that affects people with metastatic neuroendocrine tumors (mNETs). Xermelo targets the overproduction of serotonin inside mNET cells, providing a new treatment option for patients suffering from carcinoid syndrome diarrhea.
Comment: Xermelo was approved by the FDA on 28 February 2017 for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Shortly after approval, Xermelo was included in the National Comprehensive Cancer Network (NCCN) and the North American Neuroendocrine Tumor Society (NANETS) guidelines.
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