BWXT Medical Submits Actinium-225 API Drug Master File to FDA

BWXT Medical Ltd. has submitted a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for No Carrier Added (n.c.a.) Actinium-225 (Ac-225) Active Pharmaceutical Ingredient. Ac-225 is an alpha-emitting isotope utilized in targeted alpha therapies (TATs), which combine the isotope with tumor-seeking targeting vectors to destroy cancer cells while minimizing damage to healthy tissues.

The demand for Ac-225 is increasing, but there are few suppliers capable of producing high-purity actinium in significant quantities. One advanced production method involves high-energy proton spallation of thorium targets, which are produced and irradiated in collaboration with TRIUMF. This process favors the production of Ra-225, which can be isolated and loaded onto a generator. The elution of this generator yields high-purity Ac-225 without the long-lived impurity Ac-227.

Jonathan Cirtain, president and CEO of BWXT Medical, stated, “Our submission of a Drug Master File to the FDA marks a significant milestone for our company. This filing underscores our unwavering commitment to quality and regulatory excellence, ensuring that our medical isotopes meet the highest standards of safety and efficacy. It represents not just our dedication to advancing healthcare, but also our readiness to support our customers and partners in delivering critical treatments to patients in need.”

The FDA plays a crucial role in advancing public health by expediting innovations that enhance the effectiveness, safety, and affordability of medical products. Additionally, it provides the public with accurate, science-based information to help maintain and improve health. Drug Master Files (DMFs) are confidential submissions to the FDA that provide detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storage of human drug products.

An active DMF allows clinical investigators or pharmaceutical companies to reference the filing in their regulatory submissions. BWXT Medical’s Ac-225 has been used in an early clinical study, and the DMF is now ready for reference to support later-stage clinical studies and, ultimately, new drug applications.

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