SQ Innovation, in collaboration with Gerresheimer, has achieved a significant regulatory milestone with the U.S. Food and Drug Administration's (FDA) tentative approval of Lasix ONYU. This innovative combination product is designed for the home treatment of fluid overload associated with congestive heart failure, potentially transforming how this condition is managed and reducing healthcare costs.
Lasix ONYU: A Novel Approach to Diuretic Therapy
Lasix ONYU combines a high-concentration formulation of furosemide, a well-established diuretic, with Gerresheimer's advanced on-body drug delivery device. This device features a micropump technology that enables precise and controlled subcutaneous administration of the drug, adhering to a defined therapy regimen. The tentative approval signifies that Lasix ONYU has met the FDA's rigorous standards for quality, safety, and efficacy.
Pieter Muntendam, MD, Founder, President, and CEO of SQ Innovation, stated, "The FDA’s Tentative Approval is a testament to our product and the people and partners who have contributed to this great endeavor, especially the Gerresheimer team. It is an important milestone. We look forward to commercializing this highly innovative combination product as soon as we receive final approval with the aim to improve patients' quality of life and reduce healthcare costs for the elderly."
Device Design and Functionality
The Lasix ONYU device is designed with patient comfort and environmental considerations in mind. It is lightweight and compact, adhering to the patient's body for comfortable wear during drug infusion. The device features a user-friendly, one-button operation with automatic needle insertion and retraction. It comprises two components: a reusable electromechanical part, rated for 48 treatments, and a single-use sterile disposable component that comes into contact with the drug solution and the body. The reusable component is recyclable, and the disposable unit can be sterilized using radiation instead of chemical methods, reducing medical waste. This design aligns with Gerresheimer’s EcoDesign principles, aimed at increasing product lifespan and minimizing waste.
Potential for Cost Reduction and Improved Patient Outcomes
One of the key advantages of Lasix ONYU is its potential to reduce the overall cost of care. The two-component design lowers the cost per treatment, as only the disposable part needs replacement. More importantly, the device facilitates home treatment, potentially decreasing the length of hospital stays or eliminating the need for hospitalization altogether for intravenous diuretic administration. This shift towards home-based care could significantly improve the quality of life for patients with congestive heart failure, allowing them to manage their condition more independently and comfortably.
Future Availability
SQ Innovation plans to pursue full FDA approval for Lasix ONYU following the expiration of a competing product's market exclusivity in October 2025. The first Lasix ONYU products are anticipated to be available on the market by the end of 2025. Gerresheimer manages the device's production, including the disposable unit manufactured at its facility in Wackersdorf, Germany.
Dietmar Siemssen, CEO of Gerresheimer AG, noted, "The regulatory authority’s decision underlines the market readiness of our on-body drug delivery device. It also clearly demonstrates our expertise as an innovative solution provider for our customers, from product design to regulatory submission and 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, while also providing connectivity to remote therapeutic monitoring platforms."
