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

8 June 2024

BWXT Medical Ltd. has filed a Drug Master File with the U.S. Food and Drug Administration for its No Carrier Added. Actinium-225 Active Pharmaceutical Ingredient.

Ac-225, an alpha-emitting isotope, is pivotal in targeted alpha therapy (TAT), where it is combined with vectors designed to target tumors, effectively destroying cancer cells while minimizing damage to healthy tissues.

The isotope is in high demand, yet only a few suppliers are capable of producing significant quantities of pure actinium. A primary production method involves high-energy proton spallation of thorium targets, a process developed with TRIUMF. This technique generates Ra-225, which is then isolated and used in a generator. The generator's output provides pure Ac-225, free of the longer-lived impurity Ac-227.

BWXT Medical, stated, “The submission of our Drug Master File to the FDA marks a significant achievement for our company. It reflects our dedication to maintaining high standards of quality and regulatory compliance, ensuring that our medical isotopes are safe and effective. This step demonstrates our commitment to advancing healthcare and our preparedness to support our partners and customers in delivering essential treatments.”

The FDA's role is to promote public health by facilitating the development of safer, more effective, and affordable medical products, and by providing the public with accurate, science-based information on their use. Drug Master Files are submissions to the FDA that contain confidential, detailed information about the facilities, processes, or articles used in the manufacture, processing, packaging, and storage of human drug products.

An active DMF enables clinical researchers or pharmaceutical companies to reference this information in their regulatory submissions. BWXT Medical's Ac-225 has already been utilized in an early clinical study, and the DMF is now available for reference in supporting later-stage clinical trials and future new drug applications.