Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes
Lexicon Pharmaceuticals has resubmitted its New Drug Application (NDA) for sotagliflozin, aimed at improving glycemic control in people with type 1 diabetes and chronic kidney disease (CKD). This follows extensive interactions and recent feedback from the FDA. The company seeks approval for sotagliflozin as an adjunct to insulin therapy. Previously, the FDA issued a complete response letter (CRL) in 2019 regarding the NDA, and a Notice of Opportunity for Hearing (NOOH) was issued in 2021. Lexicon and the FDA agreed to hold NOOH proceedings in abeyance and explored a path for resubmission. The application holds a 'filed' status, with an anticipated six-month review and potential launch by early 2025.
- Resubmission of NDA for sotagliflozin, indicating progress.
- Potential approval for use in type 1 diabetes and CKD.
- Expected six-month review period, suggesting a quick turnaround.
- Potential launch in early 2025, offering market entry timeline.
- Previous FDA complete response letter in 2019, indicating initial concerns.
- Protracted regulatory process since 2019, indicating delays.
- Pending formal communication from FDA, indicating uncertainty until action date is established.
Resubmitting the NDA for sotagliflozin signals a significant potential advancement in the treatment of type 1 diabetes (T1D) and chronic kidney disease (CKD). This dual-purpose drug serves as an adjunct to insulin, aiming to improve glycemic control. Given that T1D patients often struggle to manage their blood glucose levels, sotagliflozin could offer substantial benefits, including reduced blood sugar levels and possibly fewer complications if approved.
From a medical perspective, the impact on patient outcomes could be noteworthy. The history of the drug, including the FDA's previous complete response letter in 2019 and subsequent negotiations, suggests thorough examination and scrutiny have been applied already. Lexicon's persistence indicates confidence in the drug's efficacy and safety profile. The anticipated six-month review period is relatively short, implying that the FDA sees potential merit in reassessing the application quickly.
Key insight: If approved, sotagliflozin could fill a critical gap in T1D management, especially for those with CKD, offering a potentially new standard of care. However, it also opens the door for ongoing monitoring and post-market surveillance to ensure long-term efficacy and safety.
Resubmission of the sotagliflozin NDA by Lexicon Pharmaceuticals could have significant financial implications. The potential approval and subsequent launch of this drug could be a
Looking at the financials, Lexicon has likely invested heavily in the development and regulatory process of sotagliflozin. If approved, the drug could diversify the company’s revenue streams, reducing its dependence on existing products. Furthermore, the possibility of commercialization in early 2025 suggests that revenue generation could commence relatively soon after approval.
Key insight: Investors should watch for further updates from the FDA within the next 30 days. Positive feedback or approval could lead to an increase in Lexicon's stock price, while any further delays or rejections might have the opposite effect. Given the volatility, risk-averse investors might want to proceed with caution.
The resubmission of the NDA for sotagliflozin involves regulatory and legal considerations that are key for investors to understand. The history of interactions with the FDA, including the 2019 complete response letter and the recent public Notice of Opportunity for Hearing (NOOH), indicates a complex approval process. Lexicon and the FDA's agreement to hold NOOH proceedings in abeyance in favor of further discussions highlights a cooperative yet cautious approach to the drug's approval.
Key insight: This legal backdrop suggests that while there is optimism, there are still hurdles to clear. Investors should be aware that approval is not guaranteed and that any legal or regulatory setbacks could affect the stock. The six-month review period provides a timeline for potential milestones but also leaves room for unexpected delays or additional requests for information from the FDA.
Lexicon Seeks Approval for Sotagliflozin as an Adjunct to Insulin Therapy for Glycemic Control in People with Type 1 Diabetes and Chronic Kidney Disease
Company Anticipates Six Month Review and Potential Launch in Early 2025
THE WOODLANDS, Texas, June 21, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following multiple interactions with and recent feedback from the U.S. Food and Drug Administration (FDA), it has resubmitted its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in people with type 1 diabetes and chronic kidney disease (CKD).
“We are confident in the benefit/risk profile of sotagliflozin for people with type 1 diabetes and CKD, and our team has been resolute in identifying and pursuing a regulatory path forward,” said Lonnel Coats, director and chief executive officer. “We are now one step closer to bringing this important potential therapy to market for the many people who suffer from type 1 diabetes and CKD, and who could benefit from an adjunct to insulin therapy for glycemic control.”
In 2019, the FDA issued a complete response letter (CRL) regarding the NDA for sotagliflozin for type 1 diabetes. In 2021, at Lexicon’s request, the FDA issued a public Notice of Opportunity for Hearing (NOOH) on whether there were grounds for denying such approval. Lexicon and FDA subsequently agreed in late 2023 to hold the NOOH proceedings in abeyance in order to engage in discussions regarding a path forward for resubmission and potential approval of the NDA. The application remains in “filed” status at the FDA and the company expects to receive a formal communication from FDA within 30 days of today’s submission establishing the action date and anticipates a six-month regulatory review period.
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 the therapeutic and commercial potential, research and clinical development and regulatory status of sotagliflozin in type 1 diabetes. In addition, this press release may also contain forward looking statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development 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 INPEFA® (sotagliflozin) in heart failure, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin in type 1 diabetes and other indications, LX9211, LX9851 and 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 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, and other subsequent disclosure documents 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.
For Investor Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
For Media Inquiries:
Alina Cocuzza
Lexicon Pharmaceuticals, Inc.
acocuzza@lexpharma.com
FAQ
What is the significance of Lexicon resubmitting the NDA for sotagliflozin?
When does Lexicon expect a decision from the FDA on sotagliflozin?
What challenges has Lexicon faced with sotagliflozin's FDA approval?
How does sotagliflozin benefit people with type 1 diabetes and CKD?
