Switzerland-based biopharmaceutical company SQ Innovation has gained tentative market approval from the US Food and Drug Administration (FDA) for Lasix ONYU, a combination product developed with German drug delivery device manufacturer Gerresheimer for the home treatment of fluid overload in congestive heart failure.
The Lasix ONYU comprises a high-concentration formulation of the diuretic furosemide and an on-body cartridge-based infusor for drug delivery.
The product has an automatic needle insertion and retraction and uses the infusor with a reusable electromechanical component designed for the delivery of 48 treatments, and a single-use sterile disposable component that is in contact with the drug solution and the body.
Gerresheimer said it developed the two-component concept in line with its ‘EcoDesign’ principles that aim to increase product lifespan and reduce waste.
According to SQ Innovation, the Lasix ONYU may reduce the total cost of care for patients in need of diuretic drug administration since it allows for home treatment – thereby reducing or eliminating the need for hospitalisation for intravenous diuretic administration – and because only the disposable part of the system needs to be replaced.
“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 SQ Innovation founder and CEO Pieter Muntendam.
“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 the patient's quality of life and reduce healthcare costs for the elderly.”
Gerresheimer CEO Dietmar Siemssen added: "The regulatory authority’s decision underlines the market readiness of our on-body drug delivery device.
“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.”
SQ Innovation plans to seek full marketing approval from the FDA for Lasix ONYU once the exclusivity period of a competing product expires in October 2025 and anticipates that it will be available in the US by the end of next year.
