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

BWXT Medical Ltd., based in Ottawa, Ontario, has officially submitted a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for their No Carrier Added (n.c.a.) Actinium-225 (Ac-225) Active Pharmaceutical Ingredient (API). Ac-225 is a crucial alpha-emitting isotope used in targeted alpha therapies (TATs), which are designed to target and kill cancer cells with minimal damage to surrounding healthy tissues.

The demand for Ac-225 is on the rise, but there are limited suppliers capable of producing this isotope in high purity and significant quantities. One advanced production method involves the high-energy proton spallation of thorium targets, a process carried out in collaboration with TRIUMF, Canada’s particle acceleration center. This method yields Ra-225, which can be processed to obtain high purity Ac-225, free from the long-lived impurity Ac-227.

Jonathan Cirtain, the president and CEO of BWXT Medical, noted that submitting the DMF to the FDA is a major achievement for the company. He emphasized that this step highlights BWXT Medical’s dedication to maintaining high standards of safety and efficacy in their medical isotopes. Cirtain expressed that this move reflects their commitment to advancing healthcare and readiness to support partners and customers in providing essential treatments to patients.

The FDA’s role is to promote public health by expediting innovations that ensure medical products are more effective, safer, and affordable. The FDA also provides the public with accurate, science-based information necessary for the safe and effective use of medical products and foods. Drug Master Files (DMFs) are confidential documents submitted to the FDA containing detailed information about facilities, processes, or articles involved in the manufacturing, processing, packaging, and storage of human drug products.

An active DMF can be referenced by clinical investigators or pharmaceutical companies in their regulatory submissions. BWXT Medical’s Ac-225 has already been utilized in early clinical trials, and the newly submitted DMF will now be available to support late-stage clinical studies and future new drug applications.

BWXT Medical Ltd. is a manufacturer specializing in custom radiopharmaceuticals, radiotherapies, and medical isotopes. Their facilities include an 80,000-square-foot cGMP manufacturing plant in Ottawa and a commercial cyclotron facility at TRIUMF. These state-of-the-art facilities enable BWXT Medical to produce high-quality nuclear medicine products. The company is a subsidiary of BWX Technologies, Inc. (NYSE: BWXT), a leader in manufacturing and engineering that provides innovative nuclear solutions for global security, clean energy, environmental restoration, nuclear medicine, and space exploration.