FDA Approves Lasix ONYU, First At-Home Subcutaneous Furosemide Infusion Device for Heart Failure
Key Insights
The FDA has approved Lasix ONYU, an innovative combination product featuring a high-concentration furosemide formulation and Gerresheimer (search)'s on-body drug delivery device for treating edema (search) in congestive heart failure (search) patients at home.
The device enables subcutaneous infusion of the diuretic (search) furosemide without requiring healthcare professional administration, potentially transforming care for patients with worsening heart failure (search) due to fluid overload.
The two-component infusor design includes a reusable electromechanical component rated for 48 treatments and a single-use disposable component, reducing treatment costs and medical waste.
The US Food and Drug Administration has granted approval to SQ Innovation (search) for Lasix ONYU, a groundbreaking combination product that enables at-home subcutaneous infusion of furosemide for patients with congestive heart failure (search). The innovative device, designed and manufactured by Gerresheimer (search), represents the first FDA-approved system allowing patients to self-administer diuretic (search) therapy without healthcare professional supervision.
Revolutionary Home Treatment Approach
Lasix ONYU combines a novel high-concentration formulation of the diuretic (search) furosemide with Gerresheimer (search)'s proprietary on-body drug delivery device. The system was specifically developed to enable subcutaneous infusion of furosemide at home for selected patients, as prescribed by clinicians, eliminating the need for hospital-based intravenous administration.
"Lasix ONYU has the potential to be transformative in the care of patients experiencing worsening heart failure (search) due to fluid overload," said Pieter Muntendam, MD, Founder, President and CEO of SQ Innovation (search). "Treating selected patients at home offers important benefits to patients, health systems and payors."
Advanced Micropump Technology
The cartridge-based infusor utilizes Gerresheimer (search)'s innovative micropump technology, enabling controlled and precise administration of the drug according to defined therapy regimens. The lightweight, compact device patches onto the patient's body, providing comfortable wear during drug infusion with simple one-button operation featuring automatic needle insertion and retraction.
Dietmar Siemssen, CEO of Gerresheimer (search) AG, emphasized the significance of the approval: "The FDA's decision underscores our expertise as an innovative solution provider for our customers, from product design to large-scale manufacturing. With our on-body devices for both small molecule drug formulations and large molecule biologics we can partner with our customers to address the global megatrend of home treatment."
Sustainable Two-Component Design
The Lasix ONYU infusor features an environmentally conscious two-component architecture consisting of a reusable electromechanical component and a single-use sterile disposable component. The reusable component is rated for delivery of 48 treatments with diuretic (search) furosemide and is fully recyclable. This design allows radiation sterilization instead of chemical sterilization for the disposable unit, preventing electronic components from entering medical waste streams.
The sustainable approach aligns with Gerresheimer (search)'s EcoDesign principles, which focus on increasing product lifespan and reducing waste generation.
Cost-Effective Care Model
The combination product offers significant potential for reducing total healthcare costs. The two-component design results in lower cost per treatment since only the disposable component requires replacement. More importantly, the infusor enables home treatment, potentially reducing hospital stay lengths or eliminating the need for hospitalization for intravenous diuretic (search) administration entirely.
Manufacturing and Market Availability
Gerresheimer (search) serves as the full-service solution provider, managing both device design and production. The disposable infusor units are manufactured at Gerresheimer's facility in Wackersdorf, Germany, using high-capacity semi-automated production lines. Production commenced earlier in 2025 in anticipation of regulatory approval.
First Lasix ONYU products are expected to reach the market before the end of 2025, marking a significant milestone in heart failure (search) management and home healthcare delivery systems.