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# No Justification for Lexicon Hearing: CDER
- URL: https://www.fdaweb.com/no-justification-for-lexicon-hearing-cder/
- Published: 2023-02-01T12:00:00.000Z
- Updated: 2026-09-14T18:14:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153675

For the fourth time in five years, CDER has again refused to approve sotagliflozin’s use in treating diabetes. In its reply to Lexicon Pharmaceuticals’ [response](https://www.fdaweb.com/cder-hearing-delay-on-nda-is-unfounded-lexicon/) to a proposed order denying the company’s request for a hearing on the Center’s proposal to refuse to approve the company’s NDA for sotagliflozin oral tablets, CDER says Lexicon “has failed to identify a genuine and substantial issue of material fact that would justify a hearing under FDA’s regulations.” The Center's [reply](https://downloads.regulations.gov/FDA-2021-N-0208-0102/attachment%5F1.pdf?ref=fdaweb.com) says that taking into consideration the arguments made in the company’s response to the proposed order, “Lexicon has not provided evidence sufficient to create a material issue of fact in dispute that, if resolved in Lexicon’s favor, would establish that the proposed drug is safe under the conditions proposed for its use. In fact, the data, information, and factual analyses in the record show that Lexicon’s NDA is not approvable because the proposed drug has not been shown to be safe. In addition, a hearing would not otherwise be in the public interest.”

In its response, Lexicon argued that the NDA was being denied based on a diabetic ketoacidosis (DKA) concern that “can be mitigated and managed through a REMS (risk evaluation and mitigation strategy) and other measures that healthcare providers and patients are already familiar with and utilizing.”

Sanofi-Aventis, Lexicon’s predecessor-in-interest, [submitted](https://www.fdaweb.com/lexicon-pharma-seeks-hearing-on-sotagliflozin-rejection/) the NDA in 3/2018 seeking an indication as an adjunct to insulin therapy to improve glycemic control in adults with Type 1 diabetes. CDER issued a complete response letter in 3/2019, stating the NDA could not be approved in its present form due to deficiencies such as data demonstrating that the addition of sotagliflozin to insulin is associated with an increased risk of DKA. The Center rejected two subsequent dispute resolution requests, leading Lexicon to request a hearing.