Curium Submits New Drug Application for Lutetium Lu 177 Dotatate Injection
(St. Louis. – 09 July 2024) – 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.
Credit: Curium Submits New Drug Application for Lutetium Lu 177 Dotatate Injection – Curium Pharma
I think it’s too soon to say this will increase access or reduce prices. But you only have to look at the pricing of generic drugs such as Cipla Lanreotide and Advanz Pharma Lanreotide, to know that is a possibility for this version of Lu177 Dotatate PRRT.
This is the second drug application for Lu177 Dotatate this year albiet via different approval routes. Read abouit the first here which is being described as a ‘generic’.
The route being taken by Curcum (505(b)(2)) is the same one Cipla took to obtain approved for Cipla Lanreotide. Approval takes time and so they are normally submitted early to gain an early foothold.
I will keep this blog live with updates.
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