Advanced Magnetics, Inc. Receives Approvable Letter From FDA For Combidex
CAMBRIDGE, Mass., March 24, 2005 -- Advanced Magnetics, Inc. announced today that the Company received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding Combidex, its investigational functional molecular imaging agent. In the approvable letter, the FDA requested additional data to demonstrate the efficacy of Combidex. The FDA suggested that the data be limited to a well defined population of specific cancer types.
The FDA indicated that its principal issues relate to the topics addressed by the Onocologic Drugs Advisory Committee on March 3rd, primarily how the data submitted by the Company could be generalized across all tumor types. The FDA stated that it was willing to work with Advanced Magnetics on how to address the issues raised in the approvable letter.
"We intend to continue our active dialogue with the FDA to determine the necessary next steps to achieve approval for Combidex," said Jerome Goldstein, Chairman, President and CEO of Advanced Magnetics. "Until we establish the nature of what the FDA believes will be acceptable additional data, we cannot speculate on what we may have to do to address the FDA's concerns or how long the process will take."
About Advanced Magnetics
Advanced Magnetics, Inc. is a developer of superparamagnetic iron oxide nanoparticles used in pharmaceutical products. As a leader in its field, Advanced Magnetics is dedicated to the development and commercialization of its proprietary nanoparticle technology for use in therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cardiovascular disease and cancer.
Posted: March 2005
- Oncologic Drugs Advisory Committee Recommends Against Approval of a Broad Indication For Combidex - March 3, 2005
- Advanced Magnetics' Combidex to be Reviewed by FDA Oncologic Drugs Advisory Committee - February 1, 2005