FDA Fast Tracks Omeros’ OMS721

The FDA has fast-tracked Omeros’ OMS721 for the treatment of atypical hemolytic uremic syndrome.

OMS721 previously secured orphan drug status for the treatment of thrombotic microangiopathies.

The company plans to begin patient enrollment later this year. It also has started a Phase 2 trial for OMS721 in complement-related renal diseases and plans to market the product as a subcutaneous injection for one or more indications.