The US Food and Drug Administration (FDA) has granted a Fast Track designation to NGM Bio’s NGM621 for the treatment of patients with geographic atrophy (GA) secondary to age-related macular degeneration. GA is an advanced form of age-related macular degeneration and is largely characterized by progressive retinal cell loss resulting in irreversible vision loss. GA affects approximately one million people in the US and about five million people globally. Currently, there are no FDA or European Medicines Agency (EMA) approved treatments for the disease. The therapy, NGM621, is a proprietary humanized Immunoglobulin 1 monoclonal antibody product candidate that is delivered via intravitreal (IVT) injection and has been engineered to potently bind to, and be a long-acting inhibitor of, complement C3 activity. NGM621 is being evaluated with dosing intervals of every four and eight weeks. NGM Bio is a clinical stage biopharma company that discovers and develops novel, life-changing medicines to treat patients with a range of diseases and unmet medical needs.
Read more here.