Lexicon Pharmaceuticals, Inc. (LXRX) announced on Friday the resubmission of its New Drug Application (NDA) for sotagliflozin to the U.S. Food and Drug Administration (FDA). The submission seeks approval for sotagliflozin as an adjunct to insulin therapy to enhance glycemic control in individuals with type 1 diabetes and chronic kidney disease.
Ahead of the market opening on Nasdaq, Lexicon shares saw a 4.7 percent increase, reaching $1.83.
The decision to resubmit followed extensive interactions and recent feedback from the FDA. Lexicon anticipates a six-month review period, targeting a potential launch in early 2025.
Previously, in 2019, the FDA issued a Complete Response Letter (CRL) concerning the NDA for sotagliflozin for type 1 diabetes. Following Lexicon's request in 2021, the FDA released a Notice of Opportunity for Hearing (NOOH) to determine if there were justifiable grounds for denying the approval.
By late 2023, an agreement was reached between Lexicon and the FDA to hold the NOOH proceedings in abeyance. This decision was aimed at facilitating discussions on the resubmission pathway and potential approval of the NDA.
Lexicon has now indicated that the application remains in "filed" status with the FDA. The company expects to receive formal communication from the FDA within 30 days from the date of submission, which will establish the action date.
Lonnel Coats, Director and Chief Executive Officer, stated, "We are confident in the benefit/risk profile of sotagliflozin for people with type 1 diabetes and chronic kidney disease (CKD). Our team has been dedicated to identifying and pursuing a regulatory path forward. This development brings us closer to introducing this potentially critical therapy for individuals suffering from type 1 diabetes and CKD, who stand to benefit from adjunctive insulin therapy for glycemic control."
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