Gerresheimer, a leading provider of innovative systems and solutions for the pharma, biotech, and cosmetics industries, announced that the U.S. Food and Drug Administration (FDA) has granted Tentative Approval for SQ Innovation’s Lasix® ONYU. This product is designed for home treatment of fluid overload in patients with congestive heart failure. Lasix ONYU combines a novel high-concentration formulation of the diuretic furosemide with Gerresheimer’s on-body drug delivery device. The Tentative Approval confirms that Lasix ONYU meets the FDA’s quality, safety, and efficacy standards, although full approval is delayed due to existing market exclusivity for a competing product until October 2025. After this exclusivity period ends, SQ Innovation will seek full approval, with the first products expected to reach the market by late 2025.
The Tentative Approval underscores Gerresheimer’s innovative capabilities and the market readiness of its on-body drug delivery device. “This milestone demonstrates the strength of our product and the teamwork behind it, especially from the Gerresheimer team,” said Pieter Muntendam, MD, Founder, President, and CEO of SQ Innovation. “We are excited to commercialize this innovative combination product once we receive final approval, as it promises to improve patients’ quality of life and reduce healthcare costs for the elderly.”
Gerresheimer’s CEO, Dietmar Siemssen, highlighted the significance of the FDA’s decision, noting it showcases the readiness of their on-body drug delivery technology. He emphasized Gerresheimer’s role as an innovative solution provider, capable of supporting customers from product design through regulatory submission and large-scale manufacturing. The company’s devices for both small molecule drugs and large biologics are poised to address the growing global trend of home treatment, offering seamless integration with remote therapeutic monitoring platforms.
The Lasix ONYU device is based on Gerresheimer’s proprietary micropump technology, which allows for controlled, precise drug administration according to a defined therapy regimen. The lightweight, compact infusor is designed for patient comfort, as it can be worn on the body while the drug is infused. It features a user-friendly, one-button operation with automatic needle insertion and retraction. The device has two components: a reusable electromechanical unit and a single-use sterile component that comes into contact with both the drug and the body. The reusable component can deliver up to 48 treatments and is recyclable. Gerresheimer’s design follows its EcoDesign principles, aiming to extend product lifespan and minimize waste by using radiation sterilization for the disposable unit and ensuring no electronic waste is produced.
The Lasix ONYU combination product also presents the potential for significant cost savings in healthcare. Its two-component design lowers the cost per treatment by requiring only the disposable part to be replaced. Furthermore, the device enables home treatment, reducing hospital stays or even eliminating the need for hospitalization for intravenous diuretic administration. This innovation has the potential to enhance patient convenience and improve overall treatment outcomes.
Gerresheimer plays a critical role in both the design and production of the device. For instance, the disposable unit is manufactured at the company’s Wackersdorf, Germany facility using a high-capacity semi-automated production line. The first products of Lasix ONYU are expected to be available by the end of 2025, following the expiration of the market exclusivity for the competing product.
