The FDA grants Fast Track and Orphan Drug status to AbbVie's (NYSE:ABBV) elazanumab for the treatment of spinal cord injury.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
A 54-subject Phase 2 study is in process. The primary endpoint is upper extremity motor score (UEMS) at week 52.
Elezanumab is a monoclonal antibody of the human immunoglobulin (Ig) G1 subtype that selectively binds to a protein called repulsive guidance molecule A (RGMa) that inhibits neuronal regeneration and functional recovery after damage to the central nervous system (CNS).
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