FDA Grants Fast Track Designation to Plasminogen Drug

The FDA has granted “Fast Track” designation to a plasminogen drug candidate for the treatment of patients with congenital plasminogen deficiency. The investigational plasminogen therapy is composed of a naturally occurring protein that is synthesized by the liver and circulates in the blood. Plasminogen plays an essential role in wound-healing, cell migration, tissue remodeling, and other processes. The drug is being investigated in a phase II/III clinical trial of patients with congenital plasminogen deficiency, where the drug has demonstrated a rapid response in lesion resolution and decreased the need for surgery.

Fast Track designation is intended to facilitate the development and expedite the review of drugs meant to treat serious or life-threatening medical conditions, as well as drugs that demonstrate the potential to address unmet medical needs. The plasminogen therapy was previously granted Orphan Drug Designation by the FDA and the European Commission.

Source: ProMetic press release, June 13, 2016.