New drug for spinal cord injury! FDA grants AbbVie RGMa targeted antibody elezanumab orphan drug eligibility and fast track eligibility!

September 29, 2020 // -- AbbVie recently announced that the U.S. Food and Drug Administration (FDA) has granted elezanumab (ABT-555) orphan drug eligibility (ODD) and fast-track eligibility (FTD), a treatment for patients with spinal cord injuries.
is a drug used to prevent, treat and diagnose rare diseases, which are commonly referred to as "orphan diseases" in the form of very low-incidence diseases.
In the U.S., rare diseases are disease types with fewer than 200,000 people, and incentives for the development of rare disease drugs include incentives for clinical development, such as tax credits related to clinical trial costs, FDA user fee deductions, FDA assistance in clinical trial design, and a seven-year market exclusive period for approved adaptations after the drug is marketed.
Fast Track Qualification (FTD) is designed to accelerate drug development and rapid review for serious diseases to address critically unsolved medical needs in key areas.
's fast-track eligibility for experimental drugs means that pharmaceutical companies can interact more frequently with the FDA during the development phase, be eligible for accelerated approval and priority review if the relevant criteria are met after submitting a listing application, and also be eligible for rolling review.
spinal cord injury (Photo: nurseslabs.com) elezanumab is a human immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to the repulsive guided molecule A (RGMa).
RGMa is an inhibitor of axon growth and an important factor in inhibiting neuron regeneration and functional recovery after central nervous system (CNS) damage.
is being studied for spinal cord injury, multiple sclerosis and acute isomorphic stroke.
, elezanumab treated spinal cord injury (NCT04295538) in a Phase 2 study.
usually results in permanent changes in motor function, sensation and other body functions beneath the injured site.
neck spinal cord injury is the most common and debilitating, and many occur in young people, usually male adults, with an average age of 43 at the time of injury.
usually caused by a fall after the age of 65.
Symptoms and signs of spinal cord injury include loss of movement, loss of sensation, including the ability to feel hot, cold, and touch, loss of control of the intestines or bladder, excessive reflexes or spasms, changes in sexual function, sexual sensitivity and fertility, pain or intense tingling due to damage to nerve fibers in the spinal cord, and difficulty breathing, coughing, or removing lung secretions.
() Origin: AbbVie Receives Orphans Drug and Fast Track Designs from the U.S. Food and Drug Administration for Elezanumab, An Investigational Monoclonal Antibody RGMa Addor, for The Treatment of Spinal Cord Injury.