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Lexicon Announces Outcome of FDA Advisory Committee for Zynquista™ (sotagliflozin) as an Adjunct to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney Disease

1. FDA advisory committee voted against Zynquista's benefits for some T1D patients. 2. Zynquista targets glycemic control in type 1 diabetes and chronic kidney disease. 3. FDA PDUFA target date set for December 20, 2024, for Zynquista's review. 4. Only 20% achieve adequate control with insulin alone; Zynquista could improve outcomes. 5. Committee supported Zynquista for alternative patient sub-populations despite the vote.

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Why Bearish?

The negative advisory vote may lower market sentiment for LXRX. Past examples show similar advisory outcomes typically impact stock prices negatively.

How important is it?

The article discusses the regulatory process critical to LXRX's future revenue from Zynquista. Regulatory setbacks often can lead to significant market reactions.

Why Short Term?

The upcoming FDA decision and current advisory vote impact immediate investor sentiment. Similar situations have shown price fluctuations around regulatory announcements.

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PDUFA target action date set for December 20, 2024 October 31, 2024 18:54 ET | Source: Lexicon Pharmaceuticals, Inc. THE WOODLANDS, Texas, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the outcome of the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting to review the company’s New Drug Application (NDA) for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The Advisory Committee voted 11 to 3 that the benefits of Zynquista do not outweigh the risks in adults with T1D and CKD, as defined in the voting question as having estimated glomerular filtration rate (eGFR) >45 to <60 mL/min.1.73 m2 or eGFR >60 mL/min/1.73 m2 and urine albumin-to-creatinine ratio (uACR) > 30mg/g. As part of the discussion, certain committee members expressed support for sotagliflozin in alternative sub-populations of people with T1D and CKD, where they believed the benefits potentially outweigh the risks. “We are disappointed in the outcome of today’s Advisory Committee vote. However, we were encouraged by the rich discussion and outpouring of support across the diabetes community in favor of sotagliflozin being made available to appropriate people with T1D and CKD,” said Dr. Mike Exton, chief executive officer and director of Lexicon Pharmaceuticals. “It’s clear from today’s discussion that an FDA-approved treatment and clear education on managing risk is urgently needed, and we believe our data supports this need. We look forward to working with the FDA as it completes its review of our NDA, and if approved, making Zynquista available to patients who could benefit from this therapy.” “Insulin is essential to managing this disease, but it is not sufficient in keeping patients within appropriate blood glucose ranges,” said Steve Edelman, MD, a professor of medicine in the Division of Endocrinology, Diabetes & Metabolism at the University of California, San Diego (UCSD), and founder and director of Taking Control Of Your Diabetes (TCOYD). “Only 20 percent of people with T1D currently achieve adequate glycemic control with insulin alone. Zynquista, if approved, would be the first oral medication for people with T1D, with potential to impact renal and cardiovascular outcomes, especially in those with CKD who face even greater disease progression risks.” Advisory Committee votes, while not binding, are considered by the FDA when making its decision regarding the potential approval of a regulatory application. As previously reported, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 20, 2024. About SotagliflozinDiscovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. About Lexicon Pharmaceuticals   Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and 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 treat disease safely and effectively. Lexicon has commercially launched one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications.  For additional information, please visit www.lexpharma.com.   Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its drug candidates, including Zynquista (sotagliflozin). In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. 

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