Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
Unicycive Therapeutics (Nasdaq: UNCY) has submitted a New Drug Application (NDA) to the FDA for Oxylanthanum Carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease patients on dialysis. The company is seeking approval via the 505(b)(2) regulatory pathway, aiming to provide a differentiated, best-in-class therapy with reduced pill burden. The NDA is based on data from three clinical studies, preclinical studies, and CMC specifications.
Notably, the FDA granted a waiver for the NDA application PDUFA fees, saving Unicycive approximately $4 million. The company is now preparing for a potential market launch, pending FDA approval. This submission marks a significant milestone in Unicycive's mission to improve treatment options for CKD patients with hyperphosphatemia.
Unicycive Therapeutics (Nasdaq: UNCY) ha presentato una Nuova Domanda di Farmaco (NDA) alla FDA per Oxylanthanum Carbonate (OLC) per trattare l'iperfosfatemia nei pazienti con malattia renale cronica in dialisi. L'azienda sta cercando l'approvazione tramite il percorso normativo 505(b)(2), con l'obiettivo di fornire una terapia differenziata e di prima classe con un carico di pillole ridotto. L'NDA si basa su dati provenienti da tre studi clinici, studi preclinici e specifiche CMC.
È importante notare che la FDA ha concesso una deroga per le spese di iscrizione PDUFA dell'applicazione NDA, risparmiando a Unicycive circa 4 milioni di dollari. L'azienda si sta ora preparando per un possibile lancio sul mercato, in attesa dell'approvazione della FDA. Questa presentazione segna una tappa significativa nella missione di Unicycive di migliorare le opzioni di trattamento per i pazienti con CKD e iperfosfatemia.
Unicycive Therapeutics (Nasdaq: UNCY) ha presentado una Nueva Solicitud de Medicamento (NDA) a la FDA para Oxylanthanum Carbonate (OLC) para tratar la hiperfosfatemia en pacientes con enfermedad renal crónica en diálisis. La compañía busca aprobación a través de la vía regulatoria 505(b)(2), con el objetivo de proporcionar una terapia diferenciada y de primera clase con una carga de pastillas reducida. La NDA se basa en datos de tres estudios clínicos, estudios preclínicos y especificaciones de CMC.
Es notable que la FDA otorgó una exención para las tarifas de presentación de NDA PDUFA, ahorrando a Unicycive aproximadamente 4 millones de dólares. La empresa se está preparando ahora para un posible lanzamiento al mercado, a la espera de la aprobación de la FDA. Esta presentación marca un hito significativo en la misión de Unicycive de mejorar las opciones de tratamiento para pacientes con CKD y hiperfosfatemia.
유니사이브 제약(Uniycive Therapeutics, Nasdaq: UNCY)은 FDA에 신약 신청서(NDA)를 제출하였으며, 이는 옥실란타늄 탄산염(OLC)으로 만성 신장 질환 환자의 고인산혈증을 치료하기 위한 것입니다. 이 회사는 505(b)(2) 규제 경로를 통해 승인을 받기 위해 노력하고 있으며, 복용량 부담이 적은 차별화된 최고급 치료법을 제공하는 것을 목표로 하고 있습니다. 이번 NDA는 3개의 임상 연구, 비임상 연구 및 CMC 사양의 데이터를 기반으로 하고 있습니다.
특히, FDA는 NDA 신청 PDUFA 수수료에 대한 면제를 부여하여 유니사이브에 약 400만 달러를 절약시켰습니다. 이 회사는 이제 FDA 승인을 기다리며 가능한 시장 출시를 준비하고 있습니다. 이번 제출은 고인산혈증을 앓고 있는 CKD 환자를 위한 치료 옵션을 개선하려는 유니사이브의 사명에서 중요한 이정표가 됩니다.
Unicycive Therapeutics (Nasdaq: UNCY) a soumis une Demande de Nouveau Médicament (NDA) à la FDA pour Oxylanthanum Carbonate (OLC) afin de traiter l'hyperphosphatémie chez les patients atteints de maladie rénale chronique sous dialyse. L'entreprise cherche à obtenir une approbation via la voie réglementaire 505(b)(2), visant à fournir une thérapie différenciée et de premier ordre avec un fardeau médicamenteux réduit. La NDA repose sur des données issues de trois études cliniques, d'études précliniques et de spécifications CMC.
Il est à noter que la FDA a accordé une dispense pour les frais de demande NDA PDUFA, permettant à Unicycive d'économiser environ 4 millions de dollars. L'entreprise se prépare maintenant à un éventuel lancement sur le marché, en attente de l'approbation de la FDA. Cette soumission représente une étape importante dans la mission d'Unicycive d'améliorer les options de traitement pour les patients atteints de CKD et d'hyperphosphatémie.
Unicycive Therapeutics (Nasdaq: UNCY) hat einen Antrag auf Zulassung eines neuen Arzneimittels (NDA) bei der FDA für Oxylanthanum Carbonate (OLC) zur Behandlung von Hyperphosphatämie bei Patienten mit chronischer Nierenerkrankung in Dialyse eingereicht. Das Unternehmen strebt eine Genehmigung über den regulatorischen Weg 505(b)(2) an, mit dem Ziel, eine differenzierte, erstklassige Therapie mit reduziertem Pillenbedarf anzubieten. Die NDA basiert auf Daten aus drei klinischen Studien, präklinischen Studien und CMC-Spezifikationen.
Bemerkenswert ist, dass die FDA eine Ausnahmegenehmigung für die NDA-Antragsgebühren (PDUFA) erteilt hat, was Unicycive etwa 4 Millionen Dollar gespart hat. Das Unternehmen bereitet sich nun auf einen möglichen Markteintritt vor, der von der Genehmigung der FDA abhängt. Diese Einreichung stellt einen bedeutenden Meilenstein in der Mission von Unicycive dar, die Behandlungsoptionen für CKD-Patienten mit Hyperphosphatämie zu verbessern.
- Submission of NDA to FDA for Oxylanthanum Carbonate (OLC)
- FDA granted waiver for PDUFA fees, saving approximately $4 million
- Potential for differentiated, best-in-class therapy with reduced pill burden
- Preparation for market launch underway, pending FDA approval
- None.
Insights
The submission of an NDA for Oxylanthanum Carbonate (OLC) is a significant milestone for Unicycive Therapeutics. This potential treatment for hyperphosphatemia in CKD patients on dialysis could address a critical need in nephrology. The 505(b)(2) regulatory pathway chosen may expedite the approval process, leveraging existing data. The waiver of PDUFA fees, saving
The NDA package's comprehensiveness, including three clinical studies and extensive preclinical data, strengthens the application. If approved, OLC could offer a reduced pill burden for patients, potentially improving adherence and quality of life. However, it's important to note that FDA approval is not guaranteed and the review process typically takes 10-12 months.
Unicycive's NDA submission for OLC represents a pivotal moment for the company's financial outlook. The
Investors should note that while this news is positive, commercialization costs and potential competition could impact future profitability. The company's ability to successfully launch and market OLC, if approved, will be crucial. Additionally, the timeline for potential revenue generation should be considered, as the FDA review process and subsequent market penetration will take time.
The development of OLC addresses a persistent challenge in managing CKD patients on dialysis. Hyperphosphatemia is associated with increased mortality and morbidity, making effective phosphate binders crucial. The potential for OLC to provide phosphate control with a reduced pill burden could significantly improve patient compliance and outcomes.
Current phosphate binders often require patients to take multiple pills several times a day, leading to poor adherence. If OLC can deliver effective phosphate control with fewer pills, it could become a preferred option for both patients and healthcare providers. However, it's important to await the full clinical data and FDA review to assess OLC's efficacy and safety profile compared to existing treatments.
LOS ALTOS, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway.
“With this NDA submission, we are excited to be one step closer to our goal of bringing OLC to patients with chronic kidney disease who are living with hyperphosphatemia,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “We believe our data support a differentiated and best-in-class therapy that will maintain phosphate control while reducing the onerous pill burden patients currently have to manage. Over the last several months, our team has worked diligently to reach this milestone, and we are now preparing to launch OLC, if approved. We are also pleased to report that the FDA granted a waiver for the NDA application Prescription Drug User Fee Act (PDUFA) fees which is a significant savings of approximately
The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the specifications and practices related to chemistry, manufacturing and controls (CMC).
About Oxylanthanum Carbonate (OLC)
Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is expected to exceed
Fosrenol® is a registered trademark of Shire International Licensing BV.
1Reason Research, LLC 2022 survey. Results here.
2Fortune Business InsightsTM, Hyperphosphatemia Treatment Market, 2021-2028
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over
Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contact:
ir@unicycive.com
(650) 543-5470
SOURCE: Unicycive Therapeutics, Inc.
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