European approval process for gallium-68 generator Eckert & Ziegler ended with success -
Radiopharma Eckert & Ziegler GmbH has received a recommendation from the European Agency drugs for approval of its pharmaceutical 68 Ge / 68 Ga generators. This achievement marks the conclusion of a comprehensive evaluation procedure and decentralized first gallium generator was approved for the clinical development of highly specific diagnostic agents. Approval for sale in the respective countries is planned in the next two months.
Gallium generators provide an inexpensive alternative to radiolabeling diagnostic probes using positron emission tomography (PET), an imaging process that can be used to determine whether the diseased tissue. The process is primarily used in the treatment of cancer. So far, fluorine-18 or carbon-11 isotopes PET has generally been used to radiolabel diagnostic probes; these radioisotopes are produced using cyclotrons which are capitally intensive large-scale facilities dedicated requiring million investment. However, gallium generator is about the size of a thermos and can come from a lot less money, reducing costs and increasing flexibility in nuclear medicine clinics.
Once it was approved, Eckert & Ziegler will also submit its documents to the US Food and Drug Administration (FDA), the establishment of a Drug Master File with the agency. This will allow parties interested in developing new drugs to consult the file and use the generator in clinical trials of drugs and other parameters.
Dr. André Heβ, member of the Board of Eckert & Ziegler AG and head of Radiopharma segment, said, "We are proud to have got the ball rolling on the first approval of the world a pharmaceutical product 68 Ge / 68 Ga generator. We also would like to encourage the departments of research and academic development in the global pharmaceutical industry to introduce more substances which may be radiolabeled with Ga-68 in clinical development. approaches 'Theranostic' that combine the diagnosis using Ga -68 PET with treatment using Yttrium-0, coupled using the same carrier molecule, are also very promising. "
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