Ever since its first FDA rejection five years ago, Lexicon Pharmaceuticals hasn’t given up hope on its Type 1 diabetes prospect sotagliflozin. Now, the company’s approval dreams could be coming into focus as the drugmaker prepares to refile its application.
After hearing recent regulatory feedback from the agency, Lexicon said it plans to submit the drug by the middle of the year, the company said in a press release.
“We have remained steadfast in our support of sotagliflozin in type 1 diabetes and have worked diligently to identify a regulatory path forward for what we believe will be an important new therapy,” CEO Lonnel Coats noted in the release.
Lexicon is hoping for an approval that clears the drug to be used as an add-on to insulin therapy for adults with Type 1 diabetes mellitus and chronic kidney disease, the company said in its fourth-quarter and full-year earnings presentation (PDF). If approved, the drug will be branded as Zynquista.
Lexicon hit the first bump on its regulatory road in 2019, when the FDA rejected its bid with a safety-related complete response letter following a 8-8 vote from an advisory committee.
At the time, Sanofi was partnered on the drug, but the French pharma jumped ship after the rejection and subsequent trial flops in Type 2 diabetes.
In the rejection, the FDA cited concerns about the risk of diabetic ketoacidosis for patients taking insulin plus Zynquista. However, Lexicon maintains that the risk can be managed and may be outweighed by patients' unmet needs.
Despite the FDA rejection, Zynquista was approved in Europe in 2019. Lexicon has a trove of phase 3 data proving Zynquista’s worth in diabetes with chronic kidney disease when paired with insulin, the company has said.
The long-awaited nod would be highly beneficial to Lexicon, which took home $1.2 million in total 2023 revenues. Net losses for the year came out to $175.6 million. At one point, some analysts had blockbuster-level expectations for the drug.
Meanwhile, the drugmaker has been able to take sotaglifozin into another indication. The med scored approval for heart failure last year—branded as Inpefa—and launched weeks later, marking the first SGLT1/SGLT2 inhibitor to hit the U.S. market. The company is also testing the drug in hypertrophic cardiomyopathy.