FDA ruling on AMAG’s application after a meeting last week with Pereira. Leerkink Swann analysts Joseph Schwartz and Eric Varma issued a note to investors after the meeting to say that they expect the firm’s manufacturing issues with the agency to be resolved by mid-April, after which the company anticipates either an approval or an action date from the FDA to make a decision on whether to clear ferumoxytol for sale.
An approval of ferumoxytol would qualify the drug as a bit of an accidental success. Pereira tells me that the company—which for much of its 28-year history was dedicated to R&D of diagnostic imaging agents—originally intended to develop the drug as a contrast agent used to diagnose cardiovascular disease. The company still has plans to develop ferumoxytol as a contrast agent for use with magnetic resonance imaging (MRI) in patients with peripheral artery disease, in which leg arteries get clogged.
In fact, AMAG has big plans to expand its ferumoxytol business, including use of the drug to treat a larger pool of CKD patients, some 1.3 million people, with less severe forms of kidney disease who are not on dialysis. The firm is also planning to launch two late-stage clinical trials this year to test the drug as a iron treatment for anemia related to abnormal uterine bleeding and anemia caused by chemotherapy in cancer patients.
