Setback for Zynquista as FDA issues CRL

23 March 2019

The US Food and Drug Administration issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista (sotagliflozin) a dual SGLT1 and SGLT2 inhibitor for the treatment of adults with type 1 diabetes in combination with insulin.

Sotagliflozin, developed by French pharma major Sanofi Euronext: SAN) and US firm Lexicon Pharmaceuticals (Nasdaq: LXRX), was seen as having the potential to be the first oral antidiabetic drug approved in the USA together with insulin therapy to improve glycemic (blood sugar) control in adults with type 1 diabetes. Consensus forecasts from EvaluatePharma suggest Zynquista, if it gains approval, could have sales of $1.16 billion by 2022.

A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form. The companies gave no indication as to what reasons the FDA had given for the CRL, or what it would require from the companies to move forward.

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