AbbVie gets orphan drug and fast track status for elezanumab

AbbVie announced that the U.S. 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 (NCT04295538) for the treatment of spinal cord injury.

“AbbVie is committed to delivering therapies that make a meaningful difference in patients’ lives,” said Michael Gold, MD, Vice President, Neuroscience Development. “Spinal cord injuries result in devastating lifelong physical, emotional and economic consequences. The FDA’s Orphan Drug and Fast Track Designation for spinal cord injury patients signals an important step forward in AbbVie’s ongoing commitment to investigating innovative scientific approaches with the hope of bringing new treatment options to patients.”