FDA GRANTS PRIORITY REVIEW OF NEW DRUG APPLICATION TO TREAT CARCINOID SYNDROME
Lexicon Pharmaceuticals today announced that the FDA has granted priority review for Telotristat Etiprate, a drug used for the treatment of carcinoid syndrome. Priority Review means that the FDA has a goal to take action on an application within six months, putting a tentative release date at the end of 2016. In August, positive top-line results were reported for their pivotal phase 3 Telotristat Etiprate study in patients with carcinoid syndrome. In March, a New Drug Application was submitted to the FDA, seeking approval for the marketing and sale of Telotristat Etiprate, an oral drug which showed benefits in patients with carcinoid syndrome that is inadequately controlled by somatostatin analog therapy. Chair of NANETS Matthew H. Kulke, MD presented the findings of the Phase 3 trial at the 2015 NANETS Neuroendocrine Tumor Symposium.