Woburn, MA, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Azurity Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved FerabrightTM (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.1
"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
IMPORTANT SAFETY INFORMATION
FERABRIGHT™ (ferumoxytol injection), for intravenous use
FERABRIGHT is 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.
WARNING: ANAPHYLAXIS AND OTHER SERIOUS
HYPERSENSITIVITY REACTIONS
Fatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol products that contain the same active ingredient as FERABRIGHT. Initial signs may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred even in patients who previously tolerated ferumoxytol.
- Only administer FERABRIGHT as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
- Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following FERABRIGHT infusion including monitoring of blood pressure and pulse during and after FERABRIGHT administration [see Warnings and Precautions (5.1)].
ADDITIONAL IMPORTANT SAFETY INFORMATION
Contraindications
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 [see Warnings and Precautions (5.1)].
Warnings and Precautions
- Anaphylaxis and Other Serious Hypersensitivity Reactions: Fatal and serious hypersensitivity reactions, including anaphylaxis presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness, have occurred in patients receiving ferumoxytol products, which contain the same active ingredient as FERABRIGHT. Other adverse reactions potentially associated with hypersensitivity have occurred, including pruritus, rash, urticaria, and wheezing. These reactions have occurred in patients who had no prior exposure to ferumoxytol as well as in patients who previously tolerated ferumoxytol.
Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with FERABRIGHT. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of ferumoxytol including FERABRIGHT may have more severe outcomes. Carefully consider the potential risks and benefits before administering FERABRIGHT to these patients. FERABRIGHT is contraindicated in patients with known hypersensitivity to ferumoxytol, any of FERABRIGHT’s components, or any other intravenous iron products [see Contraindications (4)].
Only administer FERABRIGHT as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Closely observe patients for signs and symptoms of hypersensitivity including monitoring of blood pressure and pulse during and after FERABRIGHT administration for at least 30 minutes and until clinically stable following completion of infusion. Allow at least 30 minutes after FERABRIGHT infusion for administration of any other medications that may cause serious hypersensitivity reactions or hypotension [see Dosage and Administration (2.1)].
In a clinical study in patients with iron deficiency anemia (IDA) (FERABRIGHT is not approved to treat IDA), regardless of etiology, hypersensitivity reactions were reported in 0.4% (4/997) of patients administered ferumoxytol as an intravenous infusion over at least 15 minutes. These included one patient with severe hypersensitivity reaction and three patients with moderate hypersensitivity reactions.
In clinical studies predominantly in patients with IDA and chronic kidney disease (CKD) (FERABRIGHT is not approved to treat IDA or CKD), serious hypersensitivity reactions were reported in 0.2% (4/1,806) of patients administered ferumoxytol as a rapid intravenous injection (not an approved method of administration for FERABRIGHT). Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria, or wheezing) were reported in 3.5% (63/1,806) of these patients.
In postmarketing experience with ferumoxytol, fatal and serious anaphylactic type reactions presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported [see Adverse Reactions (6.2)].
- Hypotension: FERABRIGHT may cause clinically significant hypotension. Monitor patients for signs and symptoms of hypotension following FERABRIGHT administration [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)]. In a clinical study in patients with IDA (FERABRIGHT is not approved to treat IDA), moderate hypotension was reported in 0.2% (2/997) of patients administered ferumoxytol as an intravenous infusion over 15 minutes.
In clinical studies in patients with IDA and CKD (FERABRIGHT is not approved to treat IDA or CKD), hypotension was reported in 1.9% (35/1,806) of patients, including three patients with serious hypotensive reactions, who were administered ferumoxytol as a rapid intravenous injection (not an approved method of administration for FERABRIGHT). Hypotension has also been reported in postmarketing experience [see Adverse Reactions (6.2)]. - Iron Overload: Use of FERABRIGHT can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Avoid use of FERABRIGHT in patients with iron overload.
- Magnetic Resonance Imaging Test Interference: Administration of FERABRIGHT may transiently affect the diagnostic ability of MRI. Conduct anticipated MRI studies (other than the intended FERABRIGHT brain imaging) prior to the administration of FERABRIGHT. Alteration of MRI studies may persist for up to 3 months following the FERABRIGHT dose. If MRI is required within 3 months after FERABRIGHT administration, use T1- or proton density-weighted pulse sequences to minimize the FERABRIGHT effects. MRI imaging using T2-weighted pulse sequences should not be performed earlier than 4 weeks after the administration of FERABRIGHT. Maximum alteration of vascular MRI signal is evident for 1 to 2 days following FERABRIGHT administration [see Clinical Pharmacology (12.3)].
FERABRIGHT will not interfere with X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), planar nuclear medicine imaging, or ultrasound. - Differences in Magnetic Resonance Imaging Appearance Compared to Gadolinium-Based Contrast: MRI obtained with FERABRIGHT may demonstrate different size, intensity, and pattern of contrast signal in lesions compared to images obtained with gadolinium-based contrast [see Clinical Studies (14)]. Be aware of the potentially limited interpretability of changes in lesion contrast appearance if prior images were not obtained with FERABRIGHT.
Adverse Reactions
- The most common adverse reactions (≥0.65%) are nausea, pruritus, constipation, headache, diarrhea, increased blood pressure, bleeding, hyperpigmentation, vein injury, taste alteration, burning/tingling sensation with injection, red sclera, allergic rhinitis, back pain, vomiting, and increased ALT. (6.1)
- Additional adverse reactions (≥1%) reported in clinical trials of patients with IDA or patients with IDA and CKD (using dosing regimens and indications not approved for FERABRIGHT), included dizziness, fatigue, peripheral edema, edema, abdominal pain, cough, pyrexia, dyspnea, and muscle spasm. Please note that FERABRIGHT is not approved to treat IDA or CKD and these dosing regimens are not approved for FERABRIGHT.
These are not all the possible side effects of FERABRIGHT. Please see Adverse Reactions (6) in the Prescribing Information for a full list.
The Important Safety Information does not include all the information needed to use FERABRIGHT safely and effectively. For more information and full prescribing information, please visit www.Ferabright.com.
To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch
PP-FRB-5398-US-EN-v1 10/25
References:
1. Ferabright [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc; 2025.
2. American College of Radiology Manual on Contrast Media 2025
3. Toth GB, Varallyay CG, Horvath A, et al. Current and potential imaging applications of ferumoxytol for magnetic resonance imaging. Kidney Int. 2017;92(1):47-66.
4. Adams LC, Jayapal P, Ramasamy SK, et al. Ferumoxytol-enhanced MRI in children and young adults: state of the art. AJR Am J Roentgenol. 2023;220(4):590-603.
5. Finn JP, Nguyen KL, Hu P. Ferumoxytol vs. gadolinium agents for contrast-enhanced MRI: thoughts on evolving indications, risks, and benefits. J Magn Reson Imaging. 2017;46(3):919-923.
6. Daldrup-Link HE, Theruvath AJ, Rashidi A, et al. How to stop using gadolinium chelates for magnetic resonance imaging: clinical-translational experiences with ferumoxytol. Pediatr Radiol. 2022;52(2):354-366.
7. Yagmurlu B, Hamilton BE, Szidonya L, Barajas RF, Iv M. ferumoxytol-enhanced mri in brain tumor imaging. Adv Clin Radiol. 2024;6(1):175-186.American College of Radiology. ACR Manual on Contrast Media 2025. Accessed September 3, 2025. https://www.acr.org/Clinical-Resources/Clinical-Tools-and-Reference/Contrast-Manual
8. FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings. US Food and Drug Administration. Published May 16, 2018. Accessed September 3, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-gadolinium-based-contrast-agents-gbcas-are-retained-body
About Azurity
Azurity Pharmaceuticals is a privately held company committed to delivering innovative, high-quality medicines for overlooked patients. Azurity’s global footprint is over 50 countries, with a diversified portfolio of 50+ medicines spanning 10 dosage forms and 10 key therapeutic areas. Powered by its Next-Gen Commercial Model, Azurity leverages data, analytics, and AI-driven digital tools to enhance market reach and stakeholder engagement. Our medicines have benefited millions of people. For more information, visit www.azurity.com.
FERABRIGHT™ is distributed by Azurity Pharmaceuticals, Inc.
(c) 2025 Azurity Pharmaceuticals. All rights Reserved. This is intended for viewership in US only. This press release may contain forward-looking statements subject to risks and uncertainties; actual results may differ materially.
PP-FRB-5445-US-EN-v1 10/25
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