Gerresheimer: FDA grants tentative approval of SQ innovation’s Lasix ONYU

Gerresheimer, a system and solution provider and global partner for the pharma, biotech, and cosmetics industries, announced that the US Food and Drug Administration (FDA) has granted SQ Innovation Tentative Approval for Lasix ONYU. This combination product consists of a high-concentration formulation of the diuretic furosemide and the Gerresheimer on-body drug delivery device.

Tentative Approval signifies that Lasix ONYU has met the regulatory standards for quality, safety, and efficacy required for approval in the US. Full approval is pending due to the FDA granting market exclusivity to a competing product until October 2025. SQ Innovation plans to seek full approval after the exclusivity period ends. The first market-ready products are expected by the end of 2025.

“The FDA’s Tentative Approval is a testament to our product and the people and partners who have contributed to this great endeavour, especially the Gerresheimer team,” said Pieter Muntendam, MD, Founder, President, and CEO of SQ Innovation. “It is an important milestone. We look forward to commercialising 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.”

Dietmar Siemssen, CEO of Gerresheimer AG, said, “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.”

The Lasix ONYU device is based on Gerresheimer’s proprietary micropump technology, which enables controlled and precise subcutaneous drug delivery. The lightweight, compact device attaches to the patient’s body and features one-button operation with automatic needle insertion and retraction.

The device includes a reusable electromechanical component and a single-use sterile disposable component. The reusable unit is designed for up to 48 treatments and is recyclable, while the disposable unit adheres to Gerresheimer’s EcoDesign principles, reducing waste and ensuring environmental compatibility.

Lasix ONYU supports home treatment for fluid overload in congestive heart failure, potentially reducing hospital stays and the overall cost of care. Gerresheimer manages the production of the device, with the disposable unit manufactured at its Wackersdorf facility in Germany.

SQ Innovation anticipates full approval in the US after October 2025, with products expected to be available by the end of that year.