It will now be impossible for Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) to bring its drug candidate telotristat etiprate to market before the end of 2016. The FDA has requested more time to review the new drug application (NDAA) for the drug. For now, it seems the earliest that telotristat etiprate could enter market is late 1Q2017.
Three more months
The FDA said it will require three more months to complete the review of telotristat etiprate for the carcinoid syndrome indication. The request for more time to complete the review of the candidate stemmed from the additional data that Lexicon submitted after the regulator requested more information from the company.
Following the increase in the regulatory review time, the FDA has set itself the date of Feb. 28, 2017 as the deadline for issuing a final decision on the fate of the drug. Previously, the FDA was pursuing a Nov. 30, 2016 deadline.
What’s the management saying about the development?
The management of Lexicon doesn’t look worried that it will take longer than previously anticipated to complete the review of telotristat etiprate. Lexicon’s CEO, Lonnel Coats, said that they would continue to work closely with the FDA until the regulator completes the review of the candidate. Mr. Coats is even of full of praise for the FDA for the effort the agency is putting to review the additional data they submitted to support the new drug application for telotristat etiprate, though the reported positivity could simply be a public relations move.
Special status
Lexicon’s telotristat etiprate enjoys a number of special regulatory statuses. The candidate carries both Orphan Drug and Fast-Track designations from the FDA. The regulator also committed to provide a priority review of the drug’s commercialization application.
Marketing rights
Lexicon retains commercialization rights to telotristat etiprate in the U.S. and Japan. The company is currently building the infrastructure to support its commercialization activities. Lexicon has partnered with Ipsen to commercialize the drug in Europe and other markets outside the U.S. and Japan.