scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX® Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease
scPharmaceuticals (SCPH) has received FDA approval for its supplemental New Drug Application (sNDA) to expand FUROSCIX® indication to include treating edema in adult patients with chronic kidney disease (CKD), including nephrotic syndrome. The expanded treatment is expected to be available by April 2025.
FUROSCIX is a subcutaneous injection containing 80 mg/10 mL furosemide, designed for treating edema in patients with chronic heart failure or CKD. The approval represents a significant expansion of the treatment options for patients experiencing acute fluid overload, potentially enabling them to receive treatment at home rather than requiring hospitalization.
The company has prepared for the launch through key opinion leader engagement, market research, and commercial readiness initiatives. Safety considerations include monitoring for fluid, electrolyte, and metabolic abnormalities, particularly in elderly patients and those receiving higher doses. The most common adverse reactions reported in clinical trials were site and skin reactions.
scPharmaceuticals (SCPH) ha ricevuto l'approvazione della FDA per la sua domanda di autorizzazione supplementare di nuovo farmaco (sNDA) per ampliare l'indicazione di FUROSCIX® includendo il trattamento dell'edema nei pazienti adulti con malattia renale cronica (CKD), incluso il sindrome nefrosica. Si prevede che il trattamento ampliato sarà disponibile entro aprile 2025.
FUROSCIX è un'iniezione sottocutanea contenente 80 mg/10 mL di furosemide, progettata per trattare l'edema nei pazienti con insufficienza cardiaca cronica o CKD. L'approvazione rappresenta un'importante espansione delle opzioni terapeutiche per i pazienti che sperimentano un sovraccarico acuto di liquidi, consentendo loro di ricevere trattamento a casa anziché richiedere ospedalizzazione.
L'azienda si è preparata per il lancio attraverso l'engagement di leader di opinione, ricerche di mercato e iniziative di prontezza commerciale. Le considerazioni sulla sicurezza includono il monitoraggio per anomalie nei liquidi, negli elettroliti e nel metabolismo, in particolare nei pazienti anziani e in quelli che ricevono dosi più elevate. Le reazioni avverse più comuni segnalate negli studi clinici erano reazioni nel sito di iniezione e cutanee.
scPharmaceuticals (SCPH) ha recibido la aprobación de la FDA para su solicitud de nuevo fármaco suplementario (sNDA) para ampliar la indicación de FUROSCIX® e incluir el tratamiento del edema en pacientes adultos con enfermedad renal crónica (CKD), incluyendo el síndrome nefrótico. Se espera que el tratamiento ampliado esté disponible para abril de 2025.
FUROSCIX es una inyección subcutánea que contiene 80 mg/10 mL de furosemida, diseñada para tratar el edema en pacientes con insuficiencia cardíaca crónica o CKD. La aprobación representa una expansión significativa de las opciones de tratamiento para los pacientes que experimentan sobrecarga aguda de líquidos, lo que potencialmente les permitirá recibir tratamiento en casa en lugar de requerir hospitalización.
La empresa se ha preparado para el lanzamiento a través del compromiso con líderes de opinión, investigación de mercado e iniciativas de preparación comercial. Las consideraciones de seguridad incluyen el monitoreo de anormalidades en líquidos, electrolitos y metabolismo, especialmente en pacientes ancianos y aquellos que reciben dosis más altas. Las reacciones adversas más comunes reportadas en ensayos clínicos fueron reacciones en el sitio de inyección y reacciones cutáneas.
scPharmaceuticals (SCPH)는 만성 신장 질환(CKD) 환자의 부종 치료를 포함하도록 FUROSCIX®의 적응증을 확장하기 위한 보충 신약 신청(sNDA)에 대해 FDA 승인을 받았습니다. 확대된 치료는 2025년 4월까지 제공될 것으로 예상됩니다.
FUROSCIX는 80 mg/10 mL의 푸로세미드를 포함한 피하 주사제로, 만성 심부전 또는 CKD 환자의 부종 치료를 위해 설계되었습니다. 이번 승인은 급성 체액 과다를 경험하는 환자들에게 치료 옵션을 크게 확장하는 것으로, 입원 없이 자택에서 치료를 받을 수 있는 가능성을 제공합니다.
회사는 주요 의견 리더와의 협력, 시장 조사 및 상업적 준비 이니셔티브를 통해 출시를 준비했습니다. 안전성 고려 사항에는 특히 고용량을 받는 노인 환자에서의 체액, 전해질 및 대사 이상 모니터링이 포함됩니다. 임상 시험에서 보고된 가장 일반적인 부작용은 주사 부위 및 피부 반응이었습니다.
scPharmaceuticals (SCPH) a reçu l'approbation de la FDA pour sa demande d'autorisation de médicament nouveau supplémentaire (sNDA) afin d'élargir l'indication de FUROSCIX® pour inclure le traitement de l'œdème chez les patients adultes atteints de maladie rénale chronique (CKD), y compris le syndrome néphrotique. Le traitement élargi devrait être disponible d'ici avril 2025.
FUROSCIX est une injection sous-cutanée contenant 80 mg/10 mL de furosémide, conçue pour traiter l'œdème chez les patients souffrant d'insuffisance cardiaque chronique ou de CKD. L'approbation représente une expansion significative des options de traitement pour les patients souffrant d'une surcharge liquidienne aiguë, leur permettant potentiellement de recevoir un traitement à domicile plutôt que d'exiger une hospitalisation.
L'entreprise s'est préparée au lancement par le biais de l'engagement des leaders d'opinion, de la recherche de marché et d'initiatives de préparation commerciale. Les considérations de sécurité incluent la surveillance des anomalies des fluides, des électrolytes et du métabolisme, en particulier chez les patients âgés et ceux recevant des doses plus élevées. Les réactions indésirables les plus couramment rapportées dans les essais cliniques étaient des réactions au site d'injection et cutanées.
scPharmaceuticals (SCPH) hat die FDA-Zulassung für seinen Antrag auf Zulassung eines neuen Medikaments (sNDA) erhalten, um die Indikation von FUROSCIX® zu erweitern und die Behandlung von Ödemen bei erwachsenen Patienten mit chronischer Nierenerkrankung (CKD), einschließlich nephrotischem Syndrom, einzuschließen. Die erweiterte Behandlung wird voraussichtlich bis April 2025 verfügbar sein.
FUROSCIX ist eine subkutane Injektion, die 80 mg/10 mL Furosemid enthält und zur Behandlung von Ödemen bei Patienten mit chronischer Herzinsuffizienz oder CKD entwickelt wurde. Die Genehmigung stellt eine bedeutende Erweiterung der Behandlungsoptionen für Patienten dar, die unter akutem Flüssigkeitsüberhang leiden, und ermöglicht es ihnen potenziell, die Behandlung zu Hause anstelle einer Hospitalisierung zu erhalten.
Das Unternehmen hat sich auf den Launch durch die Einbindung von Meinungsführern, Marktforschung und Initiativen zur kommerziellen Bereitschaft vorbereitet. Sicherheitsüberlegungen umfassen die Überwachung von Flüssigkeits-, Elektrolyt- und Stoffwechselanomalien, insbesondere bei älteren Patienten und solchen, die höhere Dosen erhalten. Die häufigsten in klinischen Studien berichteten Nebenwirkungen waren Reaktionen an der Injektionsstelle und Hautreaktionen.
- FDA approval expands market opportunity to include CKD patients
- Home-based treatment option reduces need for hospitalization
- Commercial launch preparations already in place
- Strategic positioning in both heart failure and CKD markets
- Product launch delayed until April 2025
- Requires frequent monitoring of multiple health parameters
- Risk of serious side effects including dehydration and hearing impairment
- Treatment may terminate prematurely due to device limitations
Insights
The FDA approval of scPharmaceuticals' supplemental New Drug Application for FUROSCIX represents a significant expansion of the drug's commercial potential. This regulatory win extends FUROSCIX's use beyond heart failure to include chronic kidney disease (CKD) patients suffering from edema, effectively doubling the addressable patient population.
This approval is particularly valuable because it leverages the company's existing commercial infrastructure while opening access to an entirely new medical specialty - nephrology. The expansion required no additional clinical development costs yet unlocks substantial new revenue potential, representing an efficient growth strategy.
FUROSCIX's unique subcutaneous delivery system provides a competitive advantage in the management of fluid overload by enabling at-home administration, potentially reducing hospitalizations for both heart failure and now CKD patients. With 37 million Americans affected by CKD, this expanded indication addresses a substantial unmet need.
The April 2025 commercial availability timeline suggests manufacturing and distribution preparations are already advanced. The company appears well-prepared, having engaged key opinion leaders and conducted market research specific to nephrology practices.
This approval firmly positions scPharmaceuticals in the broader cardiorenal space rather than being to cardiovascular applications alone, supporting more diversified growth with reduced concentration risk. For a company with a market cap of approximately
This FDA approval for FUROSCIX's expanded indication represents a clear financial catalyst for scPharmaceuticals. By leveraging their existing commercial platform to serve an additional patient population without significant new R&D investment, the company creates an opportunity for accelerated revenue growth and improved operational leverage.
The expansion into CKD treatment diversifies the company's revenue base beyond cardiology into nephrology, potentially reducing business volatility. This approval effectively allows scPharmaceuticals to amortize their fixed costs across a larger patient population, which should improve gross margins over time.
From a market positioning perspective, FUROSCIX now addresses the intersection of cardiology and nephrology - a strategic advantage as these specialties increasingly overlap in patient care. The subcutaneous delivery system offers a differentiated alternative to traditional IV diuretics, potentially commanding premium pricing in both specialties.
The company's proactive preparation, including KOL engagement and commercial readiness initiatives, suggests a well-planned launch strategy. However, successful commercialization will depend on securing favorable reimbursement and effectively educating nephrology practices on the technology's benefits.
For investors, this approval increases scPharmaceuticals' total addressable market while leveraging existing infrastructure - an efficient path to potential revenue growth. With implementation set for April 2025, the company has provided a clear timeline for evaluating commercial execution of this expanded indication.
FDA approves scPharmaceuticals’ supplemental New Drug Application to expand the FUROSCIX indication to include the treatment of edema in adult patients with chronic kidney disease, including nephrotic syndrome
FUROSCIX is expected to be available for chronic kidney disease patients in April 2025
BURLINGTON, Mass., March 06, 2025 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for FUROSCIX® to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD).
"We are thrilled to announce that the FDA has approved the sNDA for FUROSCIX, expanding the indication to include the treatment of edema in patients with chronic kidney disease. This milestone marks a significant step forward for the FUROSCIX franchise and underscores our commitment to addressing unmet needs of cardiorenal patients," said John Tucker, Chief Executive Officer of scPharmaceuticals. "In anticipation of this approval, we have taken strategic steps to ensure a successful launch, including key opinion leader engagement, comprehensive market research, and commercial readiness initiatives. We are excited to introduce FUROSCIX to nephrologists and are focused on providing treatment options to both heart failure and CKD patients experiencing acute fluid overload."
“Expanding the FUROSCIX indication to include patients with chronic kidney disease will provide a much-needed additional tool for clinicians to utilize in our management of fluid overload,” stated Suneel Udani, consulting physician at Nephrology Associates of Northern Illinois and Indiana (NANI). “Utilizing FUROSCIX can potentially help us keep our patients with heart failure and/or CKD at home while we restore and maintain euvolemia.”
INDICATION
FUROSCIX® (furosemide injection), 80 mg/10 mL for subcutaneous use is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome.
IMPORTANT SAFETY INFORMATION
FUROSCIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives.
Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.
Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.
Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.
Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.
In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.
Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.
The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.
Please see the full Prescribing Information (www.furoscix.com/prescribing-information.pdf) and Instructions for Use (www.furoscix.com/instructions-for-use.pdf).
About scPharmaceuticals
At scPharmaceuticals, we are powered by passion, driven by patient care. Our Mission is focused on advancing cardiorenal care through innovative, integrated treatments that address unmet patient needs.
Our goal is to become the foremost advocate for patient-centric cardiorenal care, driving global health improvements through specialized, multidisciplinary approaches. scPharmaceuticals is expanding its reach, offering integrated therapies and products that address diverse healthcare needs and potentially improve the lives of our patients. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential of our products to treat edema in CKD patients, advance patient care and reduce healthcare costs for patients, and the market recognition of FUROSCIX; and the timing of any of the foregoing. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include but are not limited to, our dependence on the commercial success of FUROSCIX and, if approved, our other product candidates; risks related to the receipt of regulatory approval for our product candidates; risks related to our ability to manufacture, or the ability of third parties to deliver, sufficient product for commercialization of FUROSCIX or any of our product candidates, if approved; risks related to our history of operating losses, we have a history of significant operating losses and expect to incur significant and increasing losses for the foreseeable future; we may never achieve or maintain profitability; we may need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts; the terms of our credit facility place restrictions on our operating and financial flexibility, and we may not have cash available to us in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due; clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome, and any difficulties or delays in the commencement or completion, or the termination or the potential for the results from any clinical trials to support submission of sNDAs or comparable regulatory applications; and the risk that global economic factors and uncertainties will impact the Company’s operations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at www.sec.gov, as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
Katherine Miranda
scPharmaceuticals Inc., 781-301-6869
kmiranda@scpharma.com
Investors:
Nick Colangelo
Gilmartin Group, 339-225-1047
Nick@GilmartinIR.com
FAQ
When will FUROSCIX be available for CKD patients following SCPH's FDA approval?
What is the approved dosage of FUROSCIX for edema treatment?
What are the main side effects reported in FUROSCIX clinical trials?
What patient populations are included in FUROSCIX's expanded indication?
What monitoring is required for patients using FUROSCIX?
