Lexicon Announces Receipt of Complete Response Letter for Zynquista™ (sotagliflozin)
Lexicon Pharmaceuticals (LXRX) has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for Zynquista™ (sotagliflozin). The drug was intended as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). This decision was anticipated, aligning with Lexicon's previous strategic decision to discontinue Zynquista launch preparations and focus on its clinical development pipeline. The company is now prioritizing LX9211 for diabetic neuropathic pain, with top-line data from the PROGRESS Phase 2b study expected in Q1 2025.
Lexicon Pharmaceuticals (LXRX) ha ricevuto una Lettera di Risposta Completa (CRL) dalla FDA riguardante la sua Domanda di Nuovo Farmaco per Zynquista™ (sotagliflozin). Il farmaco era destinato ad essere un complemento alla terapia insulinica per il controllo glicemico negli adulti con diabete di tipo 1 e malattia renale cronica (CKD). Questa decisione era attesa, in linea con la precedente decisione strategica di Lexicon di sospendere i preparativi per il lancio di Zynquista e concentrarsi sul proprio pipeline di sviluppo clinico. L'azienda sta ora dando priorità a LX9211 per il dolore neuropatico diabetico, con dati preliminari dallo studio PROGRESS di fase 2b attesi nel primo trimestre del 2025.
Lexicon Pharmaceuticals (LXRX) ha recibido una Carta de Respuesta Completa (CRL) de la FDA respecto a su Solicitud de Nuevo Medicamento para Zynquista™ (sotagliflozin). El medicamento estaba destinado a ser un complemento a la terapia con insulina para el control glucémico en adultos con diabetes tipo 1 y enfermedad renal crónica (ERC). Esta decisión era anticipada, alineándose con la decisión estratégica previa de Lexicon de interrumpir los preparativos para el lanzamiento de Zynquista y enfocarse en su pipeline de desarrollo clínico. La compañía ahora está priorizando LX9211 para el dolor neuropático diabético, con datos preliminares del estudio PROGRESS de fase 2b esperados para el primer trimestre de 2025.
Lexicon Pharmaceuticals (LXRX)는 FDA로부터 Zynquista™ (sotagliflozin)에 대한 새로운 의약품 신청에 관한 완전 응답 서한(CRL)을 받았습니다. 이 약물은 제1형 당뇨병과 만성 신장 질환(CKD)이 있는 성인을 위한 혈당 조절을 위한 인슐린 치료의 보조제로 사용될 예정이었습니다. 이 결정은 예상된 것이며, Lexicon의 Zynquista 출시 준비 중단과 임상 개발 파이프라인에 집중하겠다는 이전의 전략적 결정과 일치합니다. 회사는 이제 당뇨병성 신경병증 치료를 위한 LX9211에 우선 순위를 두고 있으며, PROGRESS 2b상 연구의 주요 데이터는 2025년 1분기에 공개될 예정입니다.
Lexicon Pharmaceuticals (LXRX) a reçu une Lettre de Réponse Complète (CRL) de la FDA concernant sa Demande de Nouveau Médicament pour Zynquista™ (sotagliflozin). Le médicament était destiné à être un complément à la thérapie par insuline pour le contrôle glycémique chez les adultes atteints de diabète de type 1 et de maladie rénale chronique (ERC). Cette décision était anticipée, s'alignant sur la décision stratégique précédente de Lexicon de cesser les préparatifs de lancement de Zynquista et de se concentrer sur son pipeline de développement clinique. La société donne désormais la priorité à LX9211 pour la douleur neuropathique diabétique, avec des données préliminaires de l'étude PROGRESS de phase 2b attendues au premier trimestre 2025.
Lexicon Pharmaceuticals (LXRX) hat von der FDA einen vollständigen Antwortbrief (CRL) bezüglich seines Antrags auf ein neues Medikament für Zynquista™ (sotagliflozin) erhalten. Das Medikament war als Ergänzung zur Insulintherapie zur glykämischen Kontrolle bei Erwachsenen mit Typ-1-Diabetes und chronischer Nierenerkrankung (CKD) gedacht. Diese Entscheidung war erwartet worden und steht im Einklang mit Lexicons vorheriger strategischer Entscheidung, die Vorbereitungen für die Einführung von Zynquista einzustellen und sich auf die klinische Entwicklungspipeline zu konzentrieren. Das Unternehmen priorisiert nun LX9211 zur Behandlung von diabetischer Neuropathie, wobei die vorläufigen Daten der PROGRESS-Phase-2b-Studie im ersten Quartal 2025 erwartet werden.
- Phase 2b study results for LX9211 expected in Q1 2025
- FDA rejected Zynquista NDA for type 1 diabetes and CKD treatment
- Company forced to discontinue launch preparations for Zynquista
Insights
Confirms Previously Disclosed and Anticipated FDA Decision
THE WOODLANDS, Texas, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD).
This expected communication from the FDA aligns with the company’s previously disclosed strategic decision to discontinue launch preparations for Zynquista and focus solely on its clinical development pipeline.
"We are sincerely grateful to the patients and physicians who participated in our Zynquista™ clinical trials, and the broader diabetes community who strongly advocated for Zynquista’s approval," said Mike Exton, Ph.D., chief executive officer and director of Lexicon. “Although this was not our desired outcome for sotagliflozin in this indication, we remain steadfast in our commitment to advancing our clinical pipeline, including our near-term focus on LX9211 for diabetic neuropathic pain (DPNP) with top line data from our PROGRESS Phase 2b study anticipated in Q1 2025, and pursuing innovations that we believe can profoundly benefit 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 a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, 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, 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, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, 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.
Investor Contact
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
Media Contact
Sheryl Seapy
Real Chemistry
corpcomm@lexpharma.com
FAQ
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