FDA Grants Fast Track Status to Itolizumab for Lupus Nephritis Treatment
Equillium, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its drug therapy itolizumab for the treatment of lupus nephritis (LN) (lupus-related kidney disease). The therapy has the ability to modulate both the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Given the Fast Track designation, Equillium will benefit from more frequent communications with the FDA to discuss itolizumabs development and may be eligible for accelerated approval and priority review.
The EQUALISE Phase 1b study of itolizumab in patients with lupus and lupus nephritis launched in September. The trial will be assessing the opportunity for a personalized medicine approach, identifying the dominant driver of the disease through patient’s urine.
The Lupus Foundation of America (LFA) is also working closely with the FDA in the hopes of facilitating future treatment approvals. Last year, an LFA-led delegation of experts met with the FDA to propose actionable steps to optimize clinical trials, and our advocacy work with the FDA continues through our current Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) project.
There are currently no FDA approved therapies for LN. Continue to follow the Lupus Foundation of America for updates on itolizumab. Learn more about medications used to treat lupus.