Orphan Status for Anthera’s Blisibimod

FDA has granted Anthera Pharmaceuticals an orphan drug designation for blisibimod for treating immunoglobulin A nephropathy (IgAN). The company says that blisibimod targets B-cell activating factor, which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including IgAN, systemic lupus erythematosus, and others.

Anthera is currently analyzing data from the randomized, double-blind, placebo controlled, Phase 2 BRIGHT-SC study of blisibimod in patients with IgAN. “After Week 24, patients were given the opportunity to continue blinded treatment for up to 104 weeks, discontinue treatment but continue to be followed, or discontinue from the study,” it says. “Most patients, 42 of 57, completed at least 60 weeks of evaluation and 21 completed assessments through at least 104 weeks. Anthera anticipates reporting top-line data later this month.”