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news.The FDA has completed its review of Enzon's investigational new drug application for recombinant human Mannose-Binding Lectin for the treatment of severe infections in patients who are undergoing liver transplant.
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The FDA previously approved an investigational new drug application for recombinant human Mannose-Binding Lectin (rhMBL) for the prevention and treatment of severe infections in patients with multiple myeloma.
rhMBL is specifically designed to target patients with low levels of Mannose-Binding Lectin (MBL). MBL is a human plasmin protein which helps fight infections. Over 10% of the general population is estimated to be MBL-deficient. MBL deficiency may explain why some individuals who are immunosuppressed develop infectious complications even when they receive anti-infectious treatment.
Both the liver transplant and multiple myeloma trials are expected to begin enrollment later this year.
“We believe rhMBL may have utility across a broad range of life-threatening infections,” said Jeffrey Buchalter, Enzon’s CEO. “Further, MBL-deficient patients can be readily identified through protein measures and genotyping which may provide an improved opportunity to personalize anti-infection treatment for immunosuppressed patients.”