scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX Indication in Heart Failure
scPharmaceuticals (Nasdaq: SCPH) announced FDA approval of its Supplemental New Drug Application for FUROSCIX, expanding its indication to include NYHA Class IV chronic heart failure patients. This expansion covers the most symptomatic patients with the greatest limitation on physical activity, representing about 10% of all heart failure patients nationally.
FUROSCIX is now indicated for treating congestion due to fluid overload in adult patients with chronic heart failure, regardless of NYHA functional class. This approval builds on FUROSCIX's established efficacy and safety profile, potentially preventing heart failure-related hospital admissions or readmissions.
The company views this expansion as a foundation for driving sustained long-term growth, complementing the growing adoption of FUROSCIX among cardiologists and heart failure specialists.
scPharmaceuticals (Nasdaq: SCPH) ha annunciato l'approvazione da parte della FDA della sua Domanda di Nuovo Farmaco Supplementare per FUROSCIX, ampliando la sua indicazione per includere i pazienti affetti da insufficienza cardiaca cronica NYHA Classe IV. Questa espansione riguarda i pazienti con i sintomi più gravi e la maggiore limitazione nell'attività fisica, rappresentando circa il 10% di tutti i pazienti affetti da insufficienza cardiaca a livello nazionale.
FUROSCIX è ora indicato per il trattamento della congestione dovuta a sovraccarico di fluidi in pazienti adulti con insufficienza cardiaca cronica, indipendentemente dalla classe funzionale NYHA. Questa approvazione si basa sull'efficacia e sul profilo di sicurezza consolidati di FUROSCIX, con il potenziale di prevenire ospedalizzazioni o readmissioni legate all'insufficienza cardiaca.
L'azienda considera questa espansione come una base per guidare una crescita sostenuta a lungo termine, componendo l'adozione crescente di FUROSCIX tra cardiologi e specialisti in insufficienza cardiaca.
scPharmaceuticals (Nasdaq: SCPH) anunció la aprobación de la FDA de su Solicitud Suplementaria de Nuevo Medicamento para FUROSCIX, ampliando su indicación para incluir a pacientes con insuficiencia cardíaca crónica NYHA Clase IV. Esta ampliación abarca a los pacientes más sintomáticos con la mayor limitación en la actividad física, representando aproximadamente el 10% de todos los pacientes con insuficiencia cardíaca a nivel nacional.
FUROSCIX ahora está indicado para el tratamiento de la congestión debida a la sobrecarga de fluidos en pacientes adultos con insuficiencia cardíaca crónica, independientemente de la clase funcional NYHA. Esta aprobación se basa en la eficacia y el perfil de seguridad establecidos de FUROSCIX, con el potencial de prevenir ingresos o reingresos hospitalarios relacionados con la insuficiencia cardíaca.
La empresa ve esta expansión como una base para impulsar un crecimiento sostenido a largo plazo, complementando la creciente adopción de FUROSCIX entre cardiólogos y especialistas en insuficiencia cardíaca.
scPharmaceuticals (Nasdaq: SCPH)는 FUROSCIX에 대한 보충 신약 신청이 FDA의 승인을 받았다고 발표했습니다. 이는 NYHA IV등급 만성 심부전 환자를 포함하도록 적응증을 확대한 것입니다. 이 확대는 신체 활동에 대한 제한이 가장 큰 증상이 심한 환자들을 포함하며, 이는 전국적으로 심부전 환자의 약 10%를 차지합니다.
FUROSCIX는 이제 NYHA 기능적 등급에 관계없이 만성 심부전 성인 환자의 체액 과다로 인한 혼잡 치료에 적합하다고 합니다. 이 승인은 FUROSCIX의 입증된 효능과 안전성을 기반으로 하여 심부전으로 인한 병원 입원 및 재입원을 방지할 수 있는 잠재력을 가지고 있습니다.
회사는 이 확대를 지속 가능한 장기 성장의 기반으로 보고 있으며, 심장 전문의 및 심부전 전문가들 사이에서 FUROSCIX의 채택이 증가하고 있습니다.
scPharmaceuticals (Nasdaq: SCPH) a annoncé l'approbation par la FDA de sa Demande de Nouveau Médicament Supplémentaire pour FUROSCIX, élargissant son indication aux patients souffrant d'insuffisance cardiaque chronique NYHA Classe IV. Cette extension concerne les patients les plus symptomatiques ayant la plus grande limitation de l'activité physique, représentant environ 10% de tous les patients souffrant d'insuffisance cardiaque au niveau national.
FUROSCIX est maintenant indiqué pour traiter la congestion due à une surcharge liquidienne chez les adultes souffrant d'insuffisance cardiaque chronique, quelle que soit la classe fonctionnelle NYHA. Cette approbation s'appuie sur l'efficacité et le profil de sécurité établis de FUROSCIX, pouvant prévenir les admissions ou réadmissions à l'hôpital liées à l'insuffisance cardiaque.
L'entreprise considère cette expansion comme une base pour stimuler une croissance durable à long terme, complétant l'adoption croissante de FUROSCIX parmi les cardiologues et les spécialistes de l'insuffisance cardiaque.
scPharmaceuticals (Nasdaq: SCPH) hat die FDA-Zulassung für seinen Ergänzungsantrag für ein neues Medikament für FUROSCIX angekündigt, wodurch die Indikation auf NYHA-Klasse IV chronische Herzinsuffizienz Patienten erweitert wird. Diese Erweiterung betrifft die symptomatischsten Patienten mit den größten Einschränkungen der körperlichen Aktivität und macht etwa 10% aller Herzinsuffizienzpatienten im Land aus.
FUROSCIX ist nun zur Behandlung von Stauungen aufgrund von Flüssigkeitsüberlastung bei erwachsenen Patienten mit chronischer Herzinsuffizienz indiziert, unabhängig von der NYHA-Funktionsklasse. Diese Genehmigung basiert auf der etablierten Wirksamkeit und Sicherheit von FUROSCIX und hat das Potenzial, Krankenhausaufenthalte oder -wiedereinweisungen im Zusammenhang mit Herzinsuffizienz zu verhindern.
Das Unternehmen sieht diese Erweiterung als Grundlage für ein nachhaltiges langfristiges Wachstum und ergänzt die zunehmende Verbreitung von FUROSCIX unter Kardiologen und Herzinsuffizienz-Spezialisten.
- FDA approval expands FUROSCIX indication to include NYHA Class IV chronic heart failure patients
- Expanded market potential, covering approximately 10% more heart failure patients
- Potential to prevent heart failure-related hospital admissions or readmissions
- Growing adoption among cardiologists and heart failure specialists
- Potential side effects include fluid, electrolyte, and metabolic abnormalities
- Risk of excessive diuresis causing dehydration and blood volume reduction
- Possibility of acute urinary retention in patients with severe urinary retention symptoms
Insights
The FDA's approval of scPharmaceuticals' sNDA for FUROSCIX is a significant development in heart failure treatment. By expanding the indication to include NYHA Class IV patients, who represent about
The approval strengthens FUROSCIX's market position, potentially leading to increased adoption among cardiologists and heart failure specialists. However, it's important to monitor the drug's performance in this high-risk patient group, particularly regarding safety and efficacy in real-world settings. The impact on healthcare costs and patient outcomes will be key metrics to watch in the coming months.
This FDA approval represents a positive catalyst for scPharmaceuticals (NASDAQ: SCPH). By expanding FUROSCIX's addressable market to include NYHA Class IV patients, the company could see a significant revenue boost. The expanded indication may lead to increased prescription rates and potentially higher reimbursement, given the severity of Class IV heart failure.
Investors should watch for changes in sales growth rates and market penetration in the coming quarters. The approval may also enhance the company's competitive position in the heart failure treatment landscape. However, it's important to consider potential challenges such as market education efforts and competition from established treatments. The company's ability to execute on this expanded opportunity will be important for long-term value creation.
FUROSCIX is now indicated for the treatment of congestion due to fluid overload in adult patients with chronic heart failure, regardless of New York Heart Association (NYHA) functional class
Indication expansion allows for the use of FUROSCIX in NYHA Class IV chronic heart failure patients
BURLINGTON, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) seeking to expand the FUROSCIX indication for heart failure patients. At approval, FUROSCIX was only indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure. The new indication now includes patients with NYHA Class IV chronic heart failure who represent the most symptomatic patients and those with the greatest limitation on physical activity, comprising approximately
“FDA approval of our sNDA represents a natural expansion of the FUROSCIX indication given its established efficacy and safety in treating congestion due to fluid overload in adult patients with chronic heart failure, offering the potential to prevent the need for heart failure-related hospital admission or readmission,” stated John Tucker, Chief Executive Officer of scPharmaceuticals. “The growing adoption of FUROSCIX among cardiologists and heart failure specialists, together with our other FUROSCIX life cycle management initiatives, has created a solid foundation from which we plan to drive sustained long-term growth.”
FUROSCIX® (furosemide injection) 80 mg/10mL for subcutaneous use
FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with chronic heart failure.
IMPORTANT SAFETY INFORMATION
FUROSCIX is contraindicated in patients with anuria, patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation or medical adhesives and in patients with hepatic cirrhosis.
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.
For more details, please read the full Prescribing Information at FUROSCIX.com/prescribing-information.pdf and Instructions for Use at FUROSCIX.com/instructions-for-use.pdf.
About scPharmaceuticals
scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company’s lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.
Forward-Looking Statement
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 optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, and the expansion of the FUROSCIX indication for heart failure patients. 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, the risks associated with the enrollment of patients in and timely completion of clinical trials; 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; interim, “topline” and preliminary data from our clinical trials and preclinical studies are subject to audit and verification procedures that could result in material changes in the final data; if we are unable to expand our sales and marketing capabilities or continue to enter into agreements with third parties to market and sell FUROSCIX, we may be unable to generate any revenue; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future success; we have a history of significant operating losses and expect to incur significant and increasing losses for the foreseeable future; and we may never achieve or maintain profitability;. 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:
PJ Kelleher
LifeSci Advisors, 617-430-7579
pkelleher@lifesciadvisors.com
FAQ
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