Azurity Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Ferabright^TM (ferumoxytol injection), the first and only iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.

"Ferabright is an advanced superparamagnetic iron oxide nanoparticle contrast agent engineered for high relaxivity," said Ronald Scarboro, CEO of Azurity Pharmaceuticals. "It significantly enhances image contrast and precision in brain tumor delineation compared to non-contrast MRI, offering clinicians a new tool for diagnostic imaging and improved patient care."

In a clinical trial, Ferabright-enhanced MRI significantly improved visualization of primary and secondary brain neoplasms compared with pre-contrast imaging.¹  In addition to improved imaging, Ferabright offers an extended imaging window due to its long half-life, which may support flexible MRI protocols without the need for multiple contrast administrations.¹ As an iron-based agent, Ferabright is processed through the body’s natural iron metabolism pathways,^3,6,7 potentially reducing concerns related to long-term retention associated with other contrast agents.^2,8 And unlike many other agents, Ferabright is suitable for patients with renal insufficiency,^2,3,4 enabling access to contrast-enhanced MRI while reducing exposure to heavy metals found in other contrast agents.⁵

“Ferumoxytol expands our MRI toolkit and provides an option for patients who are either contraindicated for or decline gadolinium,” said Csanad Varallyay, MD, PhD, Neuroradiologist based in Portland, Oregon, with longstanding research experience in ferumoxytol-enhanced MRI.

Ferabright will be supplied in single-dose vials of 300 mg elemental iron per 10 mL (30 mg/mL) and 510 mg elemental iron per 17 mL (30 mg/mL) for intravenous infusion over at least 15 minutes.¹ Ferabright is contraindicated in patients with known hypersensitivity to ferumoxytol, any of Ferabright’s components, or any other intravenous iron products. Reactions have included anaphylaxis.¹