November 25, 2024 | Berlin
Eckert & Ziegler Radiopharma GmbH (Eckert & Ziegler) today received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand®, by the European Commission (EC). This enables the use of the radiopharmaceutical medicinal product Theralugand® in routine clinical applications throughout the European Economic Area (EEA).
Theralugand® provides high-purity Lutetium-177 produced in compliance with GMP standards with specifications designed for the labelling of therapeutic radiopharmaceuticals. The approval unlocks its potential to support innovative cancer therapies such as those targeting neuroendocrine tumors and metastatic prostate cancer. The previous, GMP-certified Lutetium-177 was limited to investigational use in clinical studies.
Eckert & Ziegler collaborates with pharmaceutical companies worldwide to develop and manufacture Lutetium-177-based radiopharmaceuticals, furthering the reach of targeted radiotherapies for the global market. Through these partnerships, Eckert & Ziegler plays a vital role in providing innovative cancer treatments.
“We are excited to achieve the EC approval for Theralugand®, a critical step in making innovative treatment options widely available for clinical applications across Europe,” said Dr. Harald Hasselmann, CEO of Eckert & Ziegler SE. “This accomplishment reflects our dedication to the production and distribution of reliable therapeutic radiopharmaceuticals.”
Eckert & Ziegler is gearing up to meet the rising global demand for Lutetium-177 by actively expanding production capacities, ensuring a stable supply of this critical therapeutic radioisotope.