scPharmaceuticals

FDA Expands Furoscix Approval to Include Edema Treatment in CKD Patients

3 months ago

• The FDA has approved scPharmaceuticals' supplemental New Drug Application for Furoscix, extending its use to treat edema in chronic kidney disease patients, with availability expected in April 2025. • Furoscix becomes the first subcutaneous loop diuretic approved for both heart failure and CKD patients, offering an at-home alternative to traditional IV diuretic therapy. • The approval was granted without requiring additional clinical studies, based on demonstrating adequate pharmacokinetic and pharmacodynamic equivalence to standard furosemide injection.

FDA Approves Ozempic for Reducing Kidney Disease Risks in Type 2 Diabetes Patients

5 months ago

• The FDA has approved Ozempic to reduce the risk of kidney disease worsening, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. • A Phase 3 clinical trial demonstrated a 24% reduction in the risk of kidney disease progression and cardiovascular death compared to placebo with Ozempic. • Ozempic is now the most broadly indicated GLP-1 receptor agonist, offering a new treatment option for millions of adults with type 2 diabetes and chronic kidney disease. • The approval was based on the FLOW trial, which showed significant benefits in kidney and cardiovascular outcomes, leading to early termination due to efficacy.

ALLEVIATE-HF Trial Shows Cardiac Monitoring-Triggered Diuretic Use Safe in Heart Failure

7 months ago

• The ALLEVIATE-HF trial demonstrated the safety of using cardiac monitoring alerts to trigger diuretic uptitration in hospitalized patients at risk of worsening heart failure. • The intervention, involving a subcutaneous insertable cardiac monitor (ICM) and nurse-implemented diuretic adjustments, resolved symptoms in 80% of symptomatic cases. • The study found that 93% of asymptomatic patients remained symptom-free during follow-up with the intervention, suggesting a potential for proactive heart failure management. • Phase 1 results support further assessment in the larger phase 2 trial to determine the intervention's effectiveness in improving heart failure outcomes.

FDA Expands Furoscix Indication to Include NYHA Class IV Heart Failure Patients

9 months ago

• The FDA has approved scPharmaceuticals' supplemental New Drug Application (sNDA) for Furoscix, expanding its indication to include NYHA Class IV chronic heart failure patients. • This expansion allows Furoscix to be used in the most symptomatic heart failure patients, who experience the greatest limitations on physical activity, representing approximately 10% of all heart failure patients. • Furoscix offers a potential alternative to hospital admission or readmission for managing congestion due to fluid overload in adult patients with chronic heart failure. • Furoscix is designed for subcutaneous self-administration, offering an outpatient treatment option for heart failure patients.