DUESSELDORF (dpa-AFX) - Gerresheimer AG (GRRMF.PK), a German systems and solutions provider for the pharma, biotech and cosmetic industries, announced Monday that the US Food and Drug Administration has granted SQ Innovation Inc. tentative approval for Lasix ONYU for the home treatment of fluid overload in congestive heart failure.
The privately held Swiss biopharma company's 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. The ready-to-market device has veen designed, developed and manufactured by Gerresheimer.
Tentative Approval indicates that Lasix ONYU has met the regulatory standards for quality, safety and efficacy required for approval in the United States. Full approval was precluded as the FDA had granted market exclusivity in the USA for a competing product until October 2025.
Gerresheimer noted that SQ Innovation will seek full approval in the U.S. after the expiration of the regulatory exclusivity period. First products of Lasix ONYU are now expected to be available on the market by the end of 2025.
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 cartridge-based infusor was designed and developed by Gerresheimer based on its proprietary infusor platform for subcutaneous drug delivery.
Dietmar Siemssen, CEO of Gerresheimer, 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.'
On the XETRA, Gerresheimer shares were trading at 76.60 euros, up 0.86 percent.
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