09/14/2016 | Press release | Distributed by Public on 10/07/2016 13:31
PDUFA Goal Date Extended to February 28, 2017
The Woodlands, Texas, September 14, 2016 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (‘FDA’) will require additional time to complete its review of the New Drug Application (‘NDA’) for telotristat etiprate, an oral drug for the treatment of carcinoid syndrome. In a notice received from the FDA, the Prescription Drug User Fee Act (‘PDUFA’) date for its Priority Review of telotristat etiprate has been extended by three months, from November 30, 2016 to February 28, 2017. In response to an information request from the FDA, additional clinical data analyses have been submitted and the extension will provide the FDA time for a full review of the submission.
‘We look forward to continuing to work closely with the FDA throughout the remainder of the regulatory review of telotristat etiprate,’ said Lexicon President and Chief Executive Officer, Lonnel Coats. ‘We appreciate the efforts of the FDA to conduct a complete review of all of the data supporting our NDA and we are committed to bringing this potential new therapy to patients suffering from carcinoid syndrome.’
Carcinoid syndrome is a rare disease affecting thousands of cancer patients with metastatic neuroendocrine tumors (mNETs) that have spread to the liver and other organs from the gastrointestinal tract. The condition is characterized by frequent and debilitating diarrhea that often prevents patients from leading active, predictable lives, as well as facial flushing, abdominal pain, fatigue and, over time, heart valve damage.