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May 24, 2018

FDA reviews Sanofi’s application for type 1 diabetes drug

The US Food and Drug Administration (FDA) has accepted Sanofi’s regulatory submission to review the use of Zynquista as a potential treatment for adults with type 1 diabetes.

The US Food and Drug Administration (FDA) has accepted Sanofi’s regulatory submission to review the use of Zynquista as a potential treatment for adults with type 1 diabetes.

Zynquista has been developed by Sanofi in collaboration with Lexicon Pharmaceuticals, and is meant to be used in addition to insulin therapy.

The investigational drug is an oral dual inhibitor of SGLT-1 and SGLT-2 proteins known to be affect how the intestines and kidneys absorb and eliminate glucose. This blockage of proteins is expected to result in improved glucose control and other clinical benefits.

“The acceptance of the FDA filing moves us closer to providing a meaningful option for people with type 1 diabetes.”

Sanofi Development senior vice-president and global head Jorge Insuasty said: “If approved, Zynquista would be the first oral antidiabetic drug approved in the US for use by adults with type 1 diabetes, in combination with insulin.

“We look forward to working with the FDA through the review process with a view towards bringing this investigational medicine to adults with type 1 diabetes in the US.”

The new drug application (NDA) submitted for Zynquista is supported by results from the inTandem clinical trial programme conducted to evaluate the safety and efficacy of the drug candidate in a total of around 3,000 inadequately controlled type 1 diabetes patients across three Phase III clinical trials.

Lexicon Pharmaceuticals executive vice-president and chief medical officer Pablo Lapuerta said: “The acceptance of the NDA filing moves us closer to providing a meaningful option for people with type 1 diabetes and we look forward to continuing to work closely with the FDA during the review process.”

FDA action is expected under the Prescription Drug User Fee Act by March 2019.

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