ProMetic Life Sciences Inc.'s biologics license application for plasminogen replacement therapy Ryplazim was accepted by the U.S. Food and Drug Administration.
Plasminogen is a protein synthesized by the liver that circulates in the blood. It is vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
The most common condition linked to plasminogen deficiency is ligneous conjunctivitis, which is characterized by thick, woody growths on the conjunctiva of the eye, and if left untreated, can lead to corneal damage and blindness.
The U.S. FDA granted Ryplazim a priority review status, with approval expected April 14, 2018. The therapy was previously granted fast track, orphan drug and rare pediatric disease designations by the agency.
ProMetic previously reported data from a phase 2/3 trial, which showed that the treatment consistently replaced and maintained plasminogen concentration at an appropriate level and resolved all lesions in patients with congenital plasminogen deficiency.