Introduction to Lasix ONYU’s Tentative Approval
Gerresheimer, a pioneering provider of systems and solutions across pharmaceutical, biotech, and cosmetic sectors, announces the US Food and Drug Administration’s (FDA) provisional approval of SQ Innovation’s Lasix ONYU. This combination product, designed for managing fluid retention in congestive heart failure, integrates a unique high-concentration diuretic furosemide formulation with Gerresheimer’s on-body drug delivery system.
Meaning of Tentative Approval
This initial FDA approval signifies that Lasix ONYU satisfies the regulatory criteria for quality, safety, and effectiveness required within the United States. However, a competing product’s existing market exclusivity has delayed full approval until this exclusivity phase concludes in October 2025. Following this period, SQ Innovation intends to pursue complete authorization. Consequently, Lasix ONYU’s debut in the market is projected by late 2025. The interim approval highlights Gerresheimer’s prowess in innovation and its readiness to unleash the on-body delivery device to the market.
Statements from Leading Figures
According to Pieter Muntendam, MD, founder, president, and CEO of SQ Innovation, “This provisional FDA approval underscores our exceptional efforts and the dedicated contributions of our partners, notably the Gerresheimer team. It marks a critical milestone and we eagerly anticipate potential distribution upon final approval, promising enhancements to patient care and economic efficiency.”
Dietmar Siemssen, CEO of Gerresheimer AG, remarked, “The regulatory body’s response corroborates our device’s market preparedness, showcasing our adeptness as innovators from development to mass production. Our technology spans both small and large molecule delivery solutions, addressing the growing trend towards patient home care, while interfacing with remote therapeutic monitoring technologies.”
Technology and Design of the Device
The Lasix ONYU infusor, derived from Gerresheimer’s advanced micropump technology, provides subcutaneous medication delivery. The user-friendly device, featuring one-button activation with automated needle functions, comfortably adheres to patients for seamless infusion. It comprises a recyclable, reusable electromechanical unit and a sterile, drug-contacting disposable component, aligning with Gerresheimer’s EcoDesign principles. This modular design reduces waste and costs, only requiring replacement of the disposable part.
Economic and Therapeutic Benefits
Offering cost-effective treatment, the infusor minimizes hospital stays and the necessity for in-patient diuretic administration, enhancing accessibility and efficiency in patient care. Gerresheimer, beyond conception and innovation, manages the production line, with the infusor’s disposable units manufactured in Wackersdorf, Germany. SQ Innovation plans to introduce Lasix ONYU to the market post-regulatory exclusivity period. Registered by Validus Pharmaceuticals L.L.C, LASIX is a trademark used by SQ Innovation under licensing.
Company Overview
SQ Innovation Inc., based in Zug, Switzerland, and Burlington, MA, thrives as a privately-owned biopharmaceutical entity specializing in cost-effective, subcutaneous therapeutic innovations. Meanwhile, Gerresheimer continues to excel with an extensive array of drug containment and delivery solutions, asserting its global leadership across medical, pharmaceutical, and cosmetic industries.