Lexicon Pharmaceuticals, Inc. , announced that the Committee for Medicinal Products for Human Use (CHMP), the committee of the European Medicines Agency (EMA) responsible for human medicines, has adopted a positive opinion for the Marketing Authorization Application (MAA) filed by Lexicon collaborator Ipsen for XERMELO® (telotristat ethyl) 250 mg to treat carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.
The CHMP’s recommendation is now referred to the European Commission (EC), which is expected to render its final decision in the third quarter of 2017. If approved by the EC, the marketing of XERMELO will be authorized in all 28 countries of the European Union (EU), as well as Norway, Liechtenstein and Iceland.
“XERMELO was approved in the U.S. in February, and the CHMP’s positive opinion marks another important step forward in providing the first oral treatment option for adults affected by this rare disease in Europe. We thank the carcinoid syndrome community for their continued support, including the adults, families and caregivers who gave their time to participate in the clinical trials of telotristat ethyl with the goal of making this treatment a reality for patients,” said Pablo Lapuerta, M.D., executive vice president and chief medical officer.
About XERMELO (Telotristat Ethyl)
Discovered using Lexicon’s unique approach to gene science, XERMELO (telostristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSAs. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. Lexicon has built the in-house capability and infrastructure to launch and market XERMELO in the U.S., where it retains all commercialization rights. Lexicon also retains rights to market XERMELO in Japan. Lexicon has established a license and collaboration agreement with Ipsen to commercialize XERMELO in Europe and other countries outside of U.S. and Japan.
XERMELO was approved by the U.S. Food and Drug Administration on February 28, 2017 for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with metastatic NETs (mNETs) and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing a new treatment option for patients suffering from carcinoid syndrome diarrhea.
About Lexicon Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.
Kimberly Lee, D.O.
Head of Investor Relations and Corporate Strategy
Senior Director, Corporate Communications and Advocacy