ST. LOUIS, July 09, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that it has submitted its 505(b)(2) New Drug Application for Lutetium Lu 177 Dotatate Injection, which, if approved by the U.S. Food and Drug Administration (FDA), would be intended for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS). Curium’s submission represents a major step in its strategy to become a key player in the promising nuclear medicine therapeutic field.
Curium has been developing its formulation over the past several years and has ensured that its formulation avoided infringement of any Orange Book listed patents in order to expedite its path to market. Curium is excited to embark on the next phase of its journey toward delivering cancer therapies to the market as part of its mission to redefine the experience of cancer through its trusted legacy in nuclear medicine.
Curium will work closely with the FDA through the review and approval process. Curium looks forward to potential approval of its Lutetium Lu 177 Dotatate formulation so that more patients suffering from GEP-NETS may have access to the potential benefits of radioligand therapy.
Michael Patterson, Curium North America CEO commented: “Curium’s 505(b)(2) new drug application for Lutetium Lu 177 Dotatate Injection marks another important milestone for Curium in its evolution to bring new tools for patients and healthcare providers to both diagnose and now potentially treat disease. Nuclear medicine-based cancer therapies must continue to be more widely and reliably available for patients and their caregivers.”
Curium will provide further updates as it proceeds with its application through the FDA’s review process.
About Curium
Curium is a world-leading nuclear medicine company. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit curiumpharma.com.
For more information:
Jason Tilly
VP & General Counsel, North America
jason.tilly@curiumpharma.com
