NEWS
FDA Grants Rare Pediatric Disease Designation to Omeros’ MASP-3 Inhibitor Zaltenibart for Treatment of C3 Glomerulopathy
Omeros announced that its MASP-3 inhibitor zaltenibart (OMS906) received rare pediatric disease designation from the FDA for treating C3 glomerulopathy (C3G), an ultra-rare renal disorder affecting children and young adults. The company plans to initiate Phase 3 trials for C3G in 2024. Zaltenibart is also being developed for paroxysmal nocturnal hemoglobinuria (PNH), with Phase 3 studies starting this quarter. The PNH market was valued at $3.9 billion in 2023 and is projected to reach $10.1 billion by 2032. If approved, Omeros will receive a priority review voucher that can accelerate FDA review of future applications.
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