Curium Submits New Drug Application for Lutetium Lu 177 Dotatate Injection
09 Julio 2024 - 8:47AM
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 TillyVP &
General Counsel, North Americajason.tilly@curiumpharma.com