The Food and Drug Administration (FDA) has granted Orphan Drug and Fast Track designations to elezanumab (ABT-555; AbbVie) for the treatment of patients following spinal cord injury.
Elezanumab, an investigational monoclonal antibody of the human immunoglobulin (Ig)G1 isotype, works by binding selectively to repulsive guidance molecule A (RGMa), an inhibitor of axonal outgrowth. It is believed that neutralizing this inhibitor will promote neuroregeneration.
A randomized, double-blind, placebo-controlled, proof of concept phase 2 study is currently open to enrollment and will assess the efficacy and safety of elezanumab in adults with acute traumatic cervical spinal cord injury. Patients will be randomized to receive either elezanumab or placebo intravenously (IV) within 24 hours of injury and every 4 weeks thereafter through week 48 for a total of 13 doses. The study expects to enroll 54 patients.
The Company is also investigating elezanumab for the treatment of multiple sclerosis and acute ischemic stroke.
The FDA’s Orphan Drug designation is granted to medicines intended to treat or prevent rare diseases or disorders that affect fewer than 200,000 individuals. Fast Track designation allows for expedited review of therapies that are meant to treat serious or life-threatening conditions. Generally, the designation is granted to drugs that are expected to have an impact on factors such as survival and daily functioning.
For more information visit abbvie.com.
AbbVie receives Orphan Drug and Fast Track designations from the US Food and Drug Administration for elezanumab, an investigational monoclonal antibody RGMa inhibitor, for the treatment of spinal cord injury. https://www.prnewswire.com/news-releases/abbvie-receives-orphan-drug-and-fast-track-designations-from-the-us-food-and-drug-administration-for-elezanumab-an-investigational-monoclonal-antibody-rgma-inhibitor-for-the-treatment-of-spinal-cord-injury-301138702.html. Accessed September 29, 2020.