Anthera Pharmaceuticals announced their drug, blisibimod, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for treating patients with Immunoglobulin A (IgA) nephropathy.
IgA nephropathy, also knowns as Berger’s disease, is a rare kidney condition in which IgA protein gets trapped in kidneys leading to inflammation. There are currently no approved orphan drugs for this condition. Most patients are managed with a combination of therapies that may include immunosupressants, dietary fish oil supplements, cholesterol-lowering agents, and/or blood pressure-lowering agents.
Blisibimod is a B-cell activating factor (BAFF) antagonist. BAFF is elevated in a number of rare autoimmune diseases, including IgA nephropathy and systemic lupus erythematosus.
Craig Thompson, Chief Executive Officer of Anthera said
, “There remains a very high need for patients with IgA nephropathy, as no approved therapies currently exist despite the high proportion of patients who progress to end-stage renal disease. We remain optimistic that blisibimod may be a well-tolerated, disease-modifying therapeutic that targets the underlying pathology for IgAN.”
The company hopes to report data later this month regarding their Phase 2 clinical study assessing blisibimod in patients with IgA nephropathy.
The Orphan Drug Designation program is for drugs and biologics being used to treat, diagnose or prevent a rare disease, which by definition is a condition that affect fewer than 200,000 people in the United States, annually. Orphan designation qualifies the sponsor of the drug for various development incentives, including tax credits and filing fee exclusions.
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