FDA grants fast track designation for novel myasthenia gravis therapeutic
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The FDA has granted fast track designation for KYV-101, an autologous, fully human CD19 chimeric antigen receptor T-cell product candidate, to treat myasthenia gravis.
According to a release from Kyverna Therapeutics Inc. CAR T-cell therapy modifies T cells to recognize and remove B cells in a patient’s body. KYV-101 specifically targets CD19, a protein expressed on the surface of B cells, which is involved in various types of autoimmune diseases.
Fast track designation aims to facilitate and expedite development and review of new drugs to address unmet medical needs in the treatment of serious or life-threatening conditions.
The company is currently conducting two clinical trials of KYV-101 for those with lupus nephritis, an autoimmune condition where individuals are at risk of developing kidney failure and plans to commence trials of KYV-101 for systemic sclerosis, myasthenia gravis and multiple sclerosis.
“We are very happy to receive this important designation for KYV-101 in the KYSA-6 trial and remain committed to improving the lives of patients living with severe and debilitating neurological autoimmune diseases,” Kyverna CEO Peter Maag, PhD, said in the release. “This is the second time KYV-101 has received such designation, after obtaining the first one for lupus nephritis earlier this year.”