FDA Issues Complete Response Letter for Zynquista (sotagliflozin)

In continuation of my update on Zynquista (sotagliflozin)

 The U.S. Food and Drug Administration (FDA) 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.

A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form.

Sanofi and Lexicon will work closely with the FDA to determine the appropriate next steps.

About Lexicon Pharmaceuticals

Lexicon (NASDAQ: LXRX) is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its first commercial product, XERMELO® (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.

*Sotagliflozin is an investigational drug and is under regulatory review by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). The EMA and FDA have conditionally accepted Zynquista™ as the trade name for sotagliflozin.

https://pubchem.ncbi.nlm.nih.gov/compound/lx-4211#section=Structures

FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes

In continuation of my update on sotagliflozin

The Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) today voted eight to eight on the question of whether the overall benefits of Zynquista™* (sotagliflozin) outweighed the risks to support approval. Sotagliflozin is an investigational oral dual SGLT1 and SGLT2 inhibitor under regulatory review as an adjunct to insulin for the treatment of adults with type 1 diabetes (T1D). While the FDA is not required to follow the committee’s vote, the agency considers the committee’s recommendations when making its decision, which is anticipated by March 22, 2019.

Sotagliflozin, developed by Sanofi and Lexicon, has the potential to be the first oral antidiabetic drug approved in the United States together with insulin therapy to improve glycemic (blood sugar) control in adults with T1D.

“We believe in the overall benefit-risk profile of sotagliflozin for adults with type 1 diabetes who lack adequate glycemic control using insulin alone,” said Rachele Berria, MD, PhD, Global Vice President and Head of Diabetes Medical Affairs, Sanofi. “We will continue to work with the FDA through its review process to hopefully bring to patients a new treatment that can help people living with type 1 diabetes control their blood sugar and address some of the challenges of insulin-only therapy.”

Sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. About 1.3 million Americans have T1D and an estimated 40,000 people will be newly diagnosed each year in the U.S., according to the American Diabetes Association.

“In clinical trials, when used in combination with insulin therapy, sotagliflozin significantly improved glycemic control without increasing hypoglycemia,” said Pablo Lapuerta, MD, Executive Vice President and Chief Medical Officer, Lexicon. “These results could not be achieved with insulin alone. Diabetic ketoacidosis is an inherent risk of type 1 diabetes and an increase was seen with sotagliflozin compared to insulin alone. We believe this can potentially be addressed with proper education and monitoring.” 

The New Drug Application for sotagliflozin included data from the inTandem clinical trial program, which included three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled T1D. The safety and efficacy data have not yet been fully evaluated by any regulatory authority.

Sanofi also submitted a regulatory application to the European Medicines Agency (EMA) in 2018. An EMA approval decision is expected in the first half of 2019.

https://www.drugbank.ca/drugs/DB12713

https://pubchem.ncbi.nlm.nih.gov/compound/lx-4211#section=2D-Structure

FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes