FDA stands by its rejection of Lexicon's diabetes drug Zynquista

Shares in Lexicon Pharmaceuticals dropped as much as 31% on Monday after the company said the FDA has denied its appeal of a complete response letter issued earlier this year for Zynquista (sotagliflozin), which was co-developed with Sanofi, as an add-on treatment to insulin for adults with type 1 diabetes. Lexicon indicated that it intends to appeal the decision to the FDA's Center for Drug Evaluation and Research (CDER).

According to a Lexicon executive, "we plan to initiate the engagement with CDER very shortly here this month and think we will have an answer on this matter by the end of February at the latest." Lexicon indicated that it does not intend to run new analyses for review with the CDER for Zynquista.

In September, Lexicon said Sanofi had agreed to pay the company $260 million to end their partnership on the once-daily dual SGLT1 and SGLT2 inhibitor in response to results from two Phase III trials of type 2 diabetes patients with chronic kidney disease. 

Analyst Liana Moussatos of Wedbush Securities pointed out that the move to appeal to CDER "basically (means) going over the head of the office they are dealing with now." She added "we do not yet know what the FDA wants to see" as the agency has not yet approved any SGLT inhibitors for type 1 diabetes. 

Other SGLT2 inhibitors, including AstraZeneca's Farxiga (dapagliflozin), Johnson & Johnson's Invokana (canagliflozin) and Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin), are approved in the US for patients with type 2 diabetes. 

However, the FDA recently rejected AstraZeneca's filing to expand Farxiga to include type 1 diabetes, while last month a panel of FDA advisors voted against approval of Jardiance as an adjunct to insulin for adults with type 1 diabetes, saying the benefits do not outweigh the risks. 

Meanwhile, Euopean regulators approved Zynquista in April as an adjunct to insulin therapy in certain adults with type 1 diabetes. 

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