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30 Sep 2020

AbbVie’s Elezanumab receives US FDA orphan drug and fast track designations

AbbVie announced that the US Food and Drug Administration (FDA) has granted Orphan Drug and Fast Track designations for elezanumab (ABT-555), an investigational treatment for patients following spinal cord injury.

Elezanumab is a monoclonal antibody of the human immunoglobulin (Ig) G1 isotype that binds selectively to repulsive guidance molecule A (RGMa). RGMa is an inhibitor of axonal outgrowth and recognized as an important factor in inhibiting neuronal regeneration and functional recovery following central nervous system (CNS) damage. Elezanumab is being investigated to treat spinal cord injuries, multiple sclerosis and acute ischemic stroke. It is currently in a phase 2 study for the treatment of spinal cord injury.

Currently AbbVie is partnering with the Shirley Ryan AbilityLab, a global leader in physical medicine and rehabilitation, and MC10, a health digital solutions company, in a pilot study involving 20 spinal cord injury patients. The pilot study will inform the ongoing phase 2 study of elezanumab by testing optimal biosensor placement to capture surface electromyography (sEMG), among other assessments. The pilot study will be completed in approximately two months.

A spinal cord injury often causes permanent changes in motor function, sensation and other body functions below the site of the injury. Cervical spinal cord injuries are the most common and debilitating, with many occurring in younger people, typically male adults, with 43 as the average age at the time of injury. A spinal cord injury after age 65 is most often caused by a fall. Signs and symptoms of spinal cord injuries include loss of movement; loss of sensation, including the ability to feel heat, cold and touch; loss of bowel or bladder control; exaggerated reflex activities or spasms; changes in sexual function, sexual sensitivity and fertility; pain or an intense stinging sensation caused by damage to the nerve fibers in the spinal cord; and difficulty breathing, coughing or clearing secretions from lungs.

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