OMER - Omeros granted FDA's Orphan Drug designation for PNH candidate

• The U.S. Food and Drug Administration (FDA) has awarded its Orphan Drug designation to commercial-stage biopharma Omeros Corporation ( NASDAQ: OMER ) for a candidate targeted at paroxysmal nocturnal hemoglobinuria (PNH) on Thursday, according to a federal registry.
• According to the FDA, the experimental therapy is identified as “humanized immunoglobulin G4 monoclonal antibody directed against mannan-binding lectin-associated serine protease-3 (MASP-3)” in generic terms.
• PNH is an acquired blood disorder that leads to the premature breakdown of red blood cells, causing conditions such as anemia and hemoglobinuria.
• In addition to tax credits for clinical trial costs and waiver of the user fee for marketing applications, the developers of orphan drugs can claim seven years of marketing exclusivity upon regulatory approval of the treatment.
• Omeros ( OMER ) plans to start a Phase 1b clinical trial for its MASP-3 inhibitor OMS906 in PNH.

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