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
Lexicon Pharmaceuticals (LXRX) received an unfavorable vote from the FDA Advisory Committee regarding Zynquista, its oral SGLT1/SGLT2 inhibitor for type 1 diabetes (T1D) and chronic kidney disease (CKD) patients. The committee voted 11-3 against the drug's benefits outweighing its risks. Despite the negative outcome, some committee members expressed support for the drug in certain T1D and CKD sub-populations. The FDA's final decision is expected by December 20, 2024. Currently, only 20% of T1D patients achieve adequate glycemic control with insulin alone, highlighting the potential market need for Zynquista as the first oral medication for T1D patients.
Lexicon Pharmaceuticals (LXRX) ha ricevuto un voto sfavorevole dal Comitato Consultivo della FDA riguardo a Zynquista, il suo inibitore orale SGLT1/SGLT2 per i pazienti con diabete di tipo 1 (T1D) e malattia renale cronica (CKD). Il comitato ha votato 11-3 contro i benefici del farmaco rispetto ai suoi rischi. Nonostante l'esito negativo, alcuni membri del comitato hanno espresso supporto per il farmaco in determinate sub-popolazioni di T1D e CKD. La decisione finale della FDA è attesa entro il 20 dicembre 2024. Attualmente, solo il 20% dei pazienti T1D raggiunge un adeguato controllo glicemico con l'insulina da sola, evidenziando la potenziale necessità di mercato per Zynquista come prima terapia orale per i pazienti T1D.
Lexicon Pharmaceuticals (LXRX) recibió un voto desfavorable del Comité Asesor de la FDA con respecto a Zynquista, su inhibidor oral SGLT1/SGLT2 para pacientes con diabetes tipo 1 (T1D) y enfermedad renal crónica (CKD). El comité votó 11-3 en contra de que los beneficios del medicamento superen sus riesgos. A pesar del resultado negativo, algunos miembros del comité expresaron su apoyo al medicamento en ciertas subpoblaciones de T1D y CKD. Se espera que la decisión final de la FDA sea anunciada para el 20 de diciembre de 2024. Actualmente, solo el 20% de los pacientes con T1D logran un control glucémico adecuado solo con insulina, lo que resalta la necesidad potencial en el mercado para Zynquista como el primer medicamento oral para pacientes con T1D.
Lexicon Pharmaceuticals (LXRX)는 1형 당뇨병(T1D) 및 만성 신장 질환(CKD) 환자를 위한 경구용 SGLT1/SGLT2 억제제인 Zynquista에 대해 FDA 자문 위원회로부터 부정적인 투표를 받았습니다. 위원회는 약물의 이점이 위험을 초과하지 않는다고 11-3으로 투표했습니다. 부정적인 결과에도 불구하고, 일부 위원회 회원들은 특정 T1D 및 CKD 하위 집단에서 약물에 대한 지지를 표현했습니다. FDA의 최종 결정은 2024년 12월 20일까지 예상됩니다. 현재 T1D 환자의 20%만이 인슐린 단독으로 적절한 혈당 조절을 달성하고 있어, T1D 환자를 위한 최초의 경구 약물로서 Zynquista의 잠재적 시장 필요성이 강조됩니다.
Lexicon Pharmaceuticals (LXRX) a reçu un avis défavorable du Comité consultatif de la FDA concernant Zynquista, son inhibiteur oral SGLT1/SGLT2 pour les patients atteints de diabète de type 1 (T1D) et de maladie rénale chronique (CKD). Le comité a voté 11-3 contre le fait que les avantages du médicament l'emportent sur ses risques. Malgré ce résultat négatif, certains membres du comité ont exprimé leur soutien pour le médicament dans certaines sous-populations de T1D et de CKD. La décision finale de la FDA est attendue d'ici le 20 décembre 2024. Actuellement, seulement 20 % des patients T1D atteignent un contrôle glycémique adéquat uniquement avec de l'insuline, soulignant le besoin potentiel sur le marché pour Zynquista en tant que premier médicament oral pour les patients T1D.
Lexicon Pharmaceuticals (LXRX) erhielt eine ungünstige Abstimmung des FDA-Beratungsausschusses bezüglich Zynquista, des oralen SGLT1/SGLT2-Hemmers für Patienten mit Typ-1-Diabetes (T1D) und chronischer Nierenerkrankung (CKD). Der Ausschuss stimmte mit 11 zu 3 gegen die Vorteile des Medikaments im Vergleich zu dessen Risiken. Trotz des negativen Ergebnisses äußerten einige Mitglieder des Ausschusses Unterstützung für das Medikament in bestimmten T1D- und CKD-Unterpopulationen. Die endgültige Entscheidung der FDA wird für den 20. Dezember 2024 erwartet. Derzeit erreichen nur 20% der T1D-Patienten mit Insulin allein eine angemessene glykämische Kontrolle, was den potenziellen Marktbedarf für Zynquista als erstes orales Medikament für T1D-Patienten verdeutlicht.
- Potential to be first oral medication for Type 1 Diabetes patients
- Some committee members supported drug use in specific sub-populations
- Addresses large unmet medical need (80% of T1D patients don't achieve adequate glycemic control)
- FDA Advisory Committee voted 11-3 against drug approval
- Committee concluded risks outweigh benefits for target population
- Potential regulatory setback could delay or prevent market entry
Insights
The FDA Advisory Committee's negative vote (11-3) against Zynquista for T1D patients with CKD represents a significant setback for Lexicon Pharmaceuticals. The committee's primary concern centered on the risk-benefit profile in the specified patient population with eGFR and uACR parameters. However, there are several important nuances to consider:
The 20% glycemic control rate with insulin alone highlights a substantial unmet medical need. Committee members' support for alternative sub-populations suggests potential pathway modifications for approval. The December 20 PDUFA date remains crucial, as the FDA isn't bound by the committee's recommendation.
If approved, Zynquista would be pioneering as the first oral medication for T1D with potential renal and cardiovascular benefits. This dual SGLT1/SGLT2 inhibitor's unique mechanism offers broader therapeutic potential compared to selective SGLT2 inhibitors.
This vote significantly impacts Lexicon's near-term prospects and stock valuation. With Zynquista positioned as a potential first-in-class oral medication for T1D, the negative advisory vote creates substantial market uncertainty. Key financial considerations include:
The company must now navigate a challenging path to potential approval, possibly requiring additional data or population refinement. Market expectations will likely adjust downward, impacting stock price and investor confidence. Alternative development pathways or modified indications could extend timelines and increase development costs.
For a company with
PDUFA target action date set for December 20, 2024
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 Sotagliflozin
Discovered 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.
Investor Contact
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
Media Contact
Molly Devlin
Real Chemistry
corpcomm@lexpharma.com
FAQ
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