AMAG Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to ferumoxytol for its development as a diagnostic agent for Vascular-Enhanced Magnetic Resonance Imaging (VE-MRI) to improve the assessment of peripheral arterial disease in patients with known or suspected chronic kidney disease (CKD).
If approved for an imaging indication, ferumoxytol could offer an alternative to gadolinium-based contrast agents, which are required to contain a black box warning highlighting the risks of using gadolinium-based agents in patients with advanced kidney disease, a company release said.
"We are very pleased that the FDA has recognized ferumoxytol's potential to address an important unmet medical need for a safe agent that facilitates the diagnosis of arterial abnormalities in patients with compromised kidney function," stated Brian J G Pereira, president and CEO of AMAG Pharma. "We plan to initiate a phase-II study of ferumoxytol for VE-MRI for the detection of clinically significant arterial stenosis or occlusion in subjects with intermittent claudication (leg pain with walking) in the third quarter of 2008. We look forward to continuing our collaborative relationship with the FDA in the ongoing development of ferumoxytol."
Fast Track is a designation that the FDA reserves for products intended to treat a serious or life threatening condition and that demonstrate the potential to address unmet medical needs for that condition. The Fast Track process is designed to facilitate the development and expedite the review of these products, and the FDA has a number of pathways intended to meet these goals, including more frequent interactions with the FDA throughout the development process. In addition, sponsors of drugs that receive Fast Track designation can file a new drug application (NDA) on a rolling basis as data become available and have the possibility to be considered for Priority Review, which could reduce the time it takes the FDA to review the NDA from ten to six months. Fast Track designation is intended to bring valuable treatments more quickly to patients in need.
Ferumoxytol, the company's key product candidate, is being developed for use as an intravenous iron replacement therapeutic agent for the treatment of iron deficiency anaemia and as a diagnostic agent for vascular-enhanced magnetic resonance imaging to assess peripheral arterial disease. The company submitted an NDA for marketing approval of ferumoxytol as an intravenous iron replacement therapy in chronic kidney disease patients with the FDA in December 2007. The company expects FDA action on its NDA in the second half of October 2008.
AMAG Pharma is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of therapeutic iron compounds to treat anaemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.