Curium Files New Drug Application for Lutetium Lu 177 Dotatate Injection

Curium, a global leader in nuclear medicine, has announced the submission of its 505(b)(2) New Drug Application for Lutetium Lu 177 Dotatate Injection. The application is aimed at gaining approval from the U.S. Food and Drug Administration (FDA) for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS). This submission is a significant milestone in Curium's strategic vision to become a prominent player in the burgeoning field of nuclear medicine therapeutics.

Over the past several years, Curium has been meticulously developing its Lutetium Lu 177 Dotatate formulation. A crucial part of this development involved ensuring that the formulation did not infringe upon any patents listed in the Orange Book, which has facilitated a smoother and expedited path to market. The company is eager to enter the next phase of its mission, which is to deliver innovative cancer therapies, reinforcing its commitment to transforming cancer treatment through its established legacy in nuclear medicine.

Throughout the review and approval process, Curium intends to work closely with the FDA. The company is optimistic about the potential approval of its Lutetium Lu 177 Dotatate formulation, which would enable broader access to radioligand therapy for patients suffering from GEP-NETS.

Michael Patterson, CEO of Curium North America, highlighted the importance of this new drug application. He remarked that it represents another crucial step for Curium in its ongoing efforts to provide new diagnostic and therapeutic tools for patients and healthcare providers. Patterson emphasized the necessity for making nuclear medicine-based cancer therapies more widely and reliably accessible to patients and their caregivers.

Curium has pledged to keep stakeholders informed with further updates as its application progresses through the FDA’s review process.

As a world leader in nuclear medicine, Curium specializes in developing, manufacturing, and distributing high-quality radiopharmaceutical products that benefit patients globally. The company’s legacy of excellence, combined with a forward-thinking approach, underscores its commitment to innovation and unparalleled service.

Curium operates manufacturing facilities across Europe and the United States, delivering Single Photon Emission Computed Tomography (SPECT), Positron Emission Tomography (PET), and therapeutic radiopharmaceutical solutions for life-threatening conditions. Annually, Curium’s products reach over 14 million patients.

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