Eckert & Ziegler Radiopharma GmbH has received a recommendation from the European Medicines Agency for approval of its pharmaceutical 68Ge/68Ga generators. This achievement marks the conclusion of a comprehensive decentralized evaluation procedure and the first time a gallium generator has been approved for the clinical development of highly specific diagnostic agents. Approval for sale in the respective countries is expected within the next one to two months.
Gallium generators provide an inexpensive alternative for radiolabeling diagnostic probes using positron emission tomography (PET), an imaging process that can be used to determine whether tissue is diseased. The process is mainly used in cancer treatment. Until now, fluorine-18 or carbon-11 PET radioisotopes have usually been used to radiolabel diagnostic probes; these radioisotopes are produced using cyclotrons that are capitally intensive, large-scale dedicated installations requiring millions in investment. In contrast, the gallium generator is approximately the size of a thermos and can be sourced for far less money, lowering costs and increasing flexibility at nuclear medicine clinics.
Once it has received approval, Eckert & Ziegler will also submit its documents to the U.S. Food and Drug Administration (FDA), establishing a Drug Master File with the agency. This will allow parties interested in developing new drugs to refer to the dossier and use the generator in clinical tests of medications and in other settings.
Dr. André Heβ, Member of the Executive Board of Eckert & Ziegler AG and Head of the Radiopharma segment, says: "We are proud to have gotten the ball rolling on the world's first approval of a pharmaceutical 68Ge/68Ga generator. We would also like to encourage academic research and development departments in the global pharmaceutical industry to introduce more substances that can be radiolabeled with Ga-68 into clinical development. 'Theranostic' approaches that combine diagnosis using Ga-68 PET with treatment using Yttrium-90, coupled using the same carrier molecule, are also very promising."