FDA grants fast track designation for refractory progressive MS treatment
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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.
Kyverna is currently conducting two clinical trials of KYV-101 in those with lupus nephritis and plans to conduct further studies for individuals with systemic sclerosis, myasthenia gravis and MS.
“We appreciate the FDA’s support to accelerate the development of potentially life-changing CAR T-cell therapies that could greatly benefit patients living with severe and debilitating neurological autoimmune diseases,” Kyverna CEO Peter Maag, PhD, said in the release. “This marks another important milestone in our endeavor to change the treatment paradigm with KYV-101.”