EQS-News: Gerresheimer: FDA grants Approval of SQ Innovation’s Lasix® ONYU*

Gerresheimer: FDA grants Approval of SQ Innovation’s Lasix^® ONYU^*

• Innovative combination product of furosemide and on-body device
• Device designed, developed and manufactured by Gerresheimer
• First products expected to be available already in 2025 

Duesseldorf, Germany, October 13, 2025. Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetics industries, announces that the US Food and Drug Administration (FDA) granted SQ Innovation approval for Lasix ONYU for treatment of edema in congestive heart failure. Lasix ONYU is a combination product consisting of a novel high-concentration formulation of the diuretic furosemide and the Gerresheimer on-body drug delivery device (infusor). It was developed to enable subcutaneous infusion of furosemide at home for selected patients, as prescribed by a clinician without the need for a healthcare professional to administer the drug. The cartridge-based infusor was designed and developed by Gerresheimer based on its proprietary infusor platform for subcutaneous drug delivery. Gerresheimer also manages production of the device as a full-service solution provider. First products of Lasix ONYU are expected to be available on the market already in 2025. The FDA’s approval of the combination product demonstrates Gerresheimer's innovative strength and its strong partnership with customers, from product design to large-scale manufacturing.

“The FDA’s Approval is a testament to our product and the people and partners who have contributed to this large undertaking, most notably the Gerresheimer team”, says Pieter Muntendam, MD, Founder, President and CEO of SQ Innovation. “Lasix ONYU has the potential to be transformative in the care of patients experiencing worsening heart failure due to fluid overload. Treating selected patients at home offers important benefits to patients, health systems and payors.”

“The FDA’s decision underscores our expertise as an innovative solution provider for our customers, from product design to large-scale manufacturing”, says Dietmar Siemssen, CEO of Gerresheimer AG. “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, including providing connectivity to remote therapeutic monitoring platforms.”

Device based on Gerresheimer’s innovative micropump technology

The cartridge-based infusor was designed and developed by Gerresheimer based on its proprietary infusor platform for subcutaneous drug delivery. The core technology is an innovative micropump which enables controlled, precise administration of a drug product according to a defined therapy regimen.

Designed with patient comfort and the environment in mind

The lightweight, compact device is patched onto the patient’s body, making it comfortable for the patient to wear while the drug is gently infused. The user-friendly design features a simple one-button operation with automatic needle insertion and retraction. The Lasix ONYU infusor has two components, a reusable electromechanical component, and a single-use sterile disposable component that is in contact with the drug solution and the body. The reusable component, which is rated for delivery of 48 treatments with diuretic furosemide, is recyclable. Because only the disposable unit requires sterilization, radiation can be used instead of chemical sterilization, and no electronic components end up in medical waste. This two-component concept was developed in line with Gerresheimer’s EcoDesign principles, which aim to increase product lifespan and reduce waste.

Reducing total cost of care and improving patients’ quality of life

The combination product Lasix ONYU also opens up possibilities to reduce the total cost of care. The two-component design results in a lower cost per treatment, because only the disposable part of the device needs to be replaced. Most importantly, the infusor allows for home treatment, reducing the length of hospital stay or avoiding the need for hospitalization for intravenous diuretic administration altogether.

First products expected to be available already in 2025 

In addition to Gerresheimer’s role in design and development, Gerresheimer also manages production of the device as a full-service solution provider. The disposable unit for the infusor is, for example, produced at the Gerresheimer facility in Wackersdorf, Germany, on a high-capacity semi-automated line. Production commenced earlier this year in anticipation of approval and first products are expected to be available before the end of the year.

*Legal Notice
In the United States, the trademark Lasix® is used by SQ Innovation under license from Validus Pharmaceuticals L.L.C.   

Further information on Gx InPuls, Gerresheimer's on-body device for small-molecule drugs: www.gerresheimer.com/en/gx-inpuls

About Gerresheimer 
Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The Group offers a comprehensive portfolio of drug containment solutions including closures and accessories, as well as drug delivery systems, medical devices and solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, cartridges, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. Gerresheimer supports its customers with comprehensive services along the value chain and in addressing the growing demand for enhanced sustainability. With over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. Together with Bormioli Pharma, the Group generated revenues of around EUR 2.4bn in 2024 and currently employs around 13,600 people. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).    
www.gerresheimer.com 

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