SQ Innovation has reached two key regulatory milestones as part of its international expansion plans for Lasix® ONYU. The company has obtained CE marking for the device and has also received confirmation from the European Medicines Agency (EMA) that the product is eligible for review under the centralised procedure based on its technical innovation.

The CE marking confirms that the Lasix ONYU infusor for subcutaneous delivery of furosemide complies with the General Safety and Performance Requirements of the EU Medical Device Regulation (EU MDR 2017/745). This certification, supported by an EU Declaration of Conformity and assessment by a Notified Body, is required for marketing medical devices within the European Union and is recognised in several other countries. It marks an important step in the company’s global regulatory strategy and reflects its focus on meeting safety and quality standards.

In addition, the EMA has accepted the company’s subcutaneous furosemide product for evaluation under the centralised procedure. This pathway enables a single regulatory decision that applies across all EU member states. The acceptance is based on the product’s technical innovation, recognising it as a novel drug-device combination that addresses an unmet medical need.

Lasix ONYU is designed to treat oedema in patients with heart failure, a condition that is a major cause of hospital admissions, particularly among older adults. The treatment uses a subcutaneous delivery method that provides diuretic effects comparable to intravenous furosemide, while allowing administration at home. This approach has the potential to reduce hospital stays, improve patient quality of life, and lower overall healthcare costs.

Following its approval in the United States in 2025, these developments support the company’s efforts to expand access to the therapy in Europe and other markets. SQ Innovation plans to submit an application for market authorisation later this year and is also engaging with potential partners to support distribution and commercialisation outside the United States.

 

Source: prnewswire.com

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