FDA Approval Sought for Telotristat Etiprate for Carcinoid Syndrome

Excerpt:

“A new drug application (NDA) has been submitted to the FDA for telotristat etiprate as a treatment for carcinoid syndrome in patients with metastatic neuroendocrine tumors (NETs), according to a statement from the drug’s developer, Lexicon Pharmaceuticals.

“The application was based on data from two phase III trials, both of which demonstrated significant reductions in the frequency of daily bowel movements with telotristat etiprate versus placebo. In the first study, TELESTAR, telotristat etiprate reduced daily bowel movements by up to 35%. In the second study, TELECAST, there was also a significant reduction in bowel movements (P ≤.004), although the exact data were not yet released.

“The FDA will review the NDA within 60 days of submission, at which point the agency will assign a review deadline under the Prescription Drug User Fee Act. Lexicon requested a priority review for the NDA, which would provide a 6-month deadline if the designation is granted.”

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