Provisional FDA Approval: SQ Innovation and Gerresheimer Launch Lasix ONYU

The Swiss biopharma company SQ Innovation has received preliminary market approval from the U.S. Food and Drug Administration (FDA) for its innovative product Lasix ONYU. This development occurs in close collaboration with the German specialist in drug delivery devices, Gerresheimer. Lasix ONYU is specifically designed for home therapy of fluid overload in chronic heart failure. Technologically, the product impresses with its rather sophisticated structure: it combines a highly concentrated formulation of the diuretic Furosemide with a specially developed, body-worn infuser. This device features an automatic needle insertion and retraction system and consists of a reusable electromechanical component for up to 48 treatments as well as a sterile disposable part that comes into contact with the drug solution and the body. Gerresheimer emphasizes that the two-part construction follows the so-called 'EcoDesign' principle to extend product lifespan and reduce waste. This clever design strategy could enable significant cost savings in healthcare, as the system allows for home therapy that can make hospital stays for intravenous diuretic administration obsolete. SQ Innovation's founder and CEO, Pieter Muntendam, views the FDA's decision as a significant milestone. He disclosed that the final market entry is targeted for October 2025, following the expiration of a competing product's protection period. Gerresheimer CEO Dietmar Siemssen added that the regulatory authority's decision confirms the market readiness of their device. The focus is not only on home use but also on connectivity with platforms for remote monitoring of therapeutic applications.