The US Food and Drug Administration鈥檚 (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (AdCom) has again voted against the approval of Lexicon Pharmaceutical鈥檚 Zynquista (sotagliflozin).
The AdCom voted 3-11 against Zynquista as an add-on treatment to insulin therapy for managing blood glucose levels in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The committee noted that the therapy鈥檚 benefits do not outweigh its risks.
Following the latest AdCom vote, Lexicon鈥檚 stock was down by 38.7% at market open today (1 November), compared to market close on 30 October, as trading was suspended yesterday (31 October) on account of the AdCom vote.
The FDA had previously convened an AdCom to evaluate Zynquista鈥檚 efficacy in 2019. The panel voted 8-8 to decide whether the drug’s overall benefits outweighed the associated risks. The FDA ultimately declined to approve Zynquista at that time. The company provided additional data of the matched type 2 diabetes (T2D)-CKD population from the SCORED trial (NCT03315143) in the most recent AdCom, along with post hoc subgroup analysis from the three Tandem studies.
Zynquista is an oral dual inhibitor of the sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2), which play a role in glucose uptake and reabsorption. In 2019, the European Medicines Agency (EMA) approved the therapy as an adjunct treatment to insulin in T1D and CKD. The therapy is also approved by the FDA to reduce the risk of cardiovascular death and heart failure in patients with either heart failure or T2D, CKD and other cardiovascular risk factors. It is marketed as Inpefa for the cardiovascular indication.
Lexicon is seeking approval for Zynquista in patients with T1D and CKD who had an estimated glomerular filtration rate (eGFR) of 45 to less than 60 or an eGFR of greater than 60 with a urine albumin-to-creatinine ratio (uACR) of 30 or greater.
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By GlobalDataWhile the FDA AdCom was not convinced of Zynquista鈥檚 efficacy in this population, some members did note that therapy鈥檚 benefit outweighed its risks in a subpopulation of patients who had an eGFR of 60 to less than 90 and those who have mild to moderate kidney disease. However, experts wanted more data to establish Zynquista鈥檚 efficacy in the subpopulation.
An AdCom is convened upon request of the FDA to review and evaluate the safety and efficacy data of a particular therapy. However, the AdCom recommendations are non-binding, with the final decision ultimately made by the FDA.
