Categories
Change Password!
Reset Password!
For patients with spinal cord injury, Elezanumab has been
given Fast Track and Orphan Drug designations by the United States Food and
Drug Administration (USFDA).
For managing individuals having acute traumatic cervical spinal cord injury, elezanumab (an investigational monoclonal antibody of the human immunoglobulin G1 isotype) has received Fast Track and Orphan Drug designations by FDA as per notification published on 28 September 2020. This investigational antibody selectively binds to repulsive guidance molecule A (a suppressor of axonal outgrowth). It is believed that the neutralization of this inhibitor will promote neuroregeneration.
A randomized, proof of concept phase 2, double-blind, placebo-controlled analysis will be carried out to explore elezanumab's safety and efficacy in subjects having spinal cord injury. This trial is open to recruitment (expected to recruit 54 patients) and the participants will be randomly allocated to receive either elezanumab therapy or placebo intravenously within 24 hours of injury. Every four weeks, this will be continued through week 48 for a total of 13 dosages.
The role of elezanumab to manage patients with multiple sclerosis and acute ischemic stroke is also being evaluated. The FDA’s Orphan Drug designation is generally granted to therapeutics that are intended to prevent or manage rare disorders impacting fewer than 200,000 people.
The Fast Track designation permits an accelerated review of therapies that are
meant to manage life-threatening or serious conditions. Generally, this
designation is given to drugs that are anticipated to have a vital impact on
survival and daily functioning.
MPR
Elezanumab Granted Orphan Drug, Fast Track Designations for Spinal Cord Injury
Comments (0)