Dec. 09, 2019 : The U.S. Food and Drug Administration (FDA) approved Fast Track designation for Equillium’s itolizumab for the treatment of lupus nephritis. Equillium started the EQUALISE Phase 1b study of itolizumab in patients with lupus and lupus nephritis in September 2019.
The FDA’s Fast Track program is designed in order to facilitate the development of new treatments for serious or life-threatening conditions for which there is a considerable unmet medical need.
Frequent meetings or communications of Companies with investigational drugs that receive Fast Track designation benefit more with the FDA to discuss the drug’s development plan and may be eligible for accelerated approval and priority review.
Receiving Fast Track designation recognizes the capable therapeutic potential of itolizumab for the treatment for lupus nephritis for the most part given its ability just to modulate both the activity and trafficking of effector T cells. https://fda.einnews.com/pr_news/504425591/equillium-granted-u-s-fda-fast-track-designation-for-itolizumab-for-the-treatment-of-lupus-nephritis