FDA grants fast track designation for refractory progressive MS treatment

The FDA has granted fast track designation for an autologous, fully human CD19 chimeric antigen receptor T-cell product candidate to treat those with refractory progressive multiple sclerosis, according to the manufacturer.
In a release, Kyverna Therapeutics Inc. said the novel therapeutic, KYV-101, targets CD19, a protein expressed on the surface of B cells, a telltale marker in various autoimmune diseases.
Fast track designation aims to facilitate and expedite development and review of new drugs that address unmet medical needs in the treatment of a serious or life-threatening condition.

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