FDA grants Kyverna Therapeutics fast track designation for myasthenia gravis treatment

Betsy Goodfellow | December 14, 2023 | News story | Medical Communications FDA, Kyverna Therapeutics, Musculo-skeletal disorder, myasthenia gravis 

Kyverna Therapeutics has announced that it has gained fast track designation from the US Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, which is intended for the treatment of myasthenia gravis (MG).

This designation aims to expedite the development and review processes for new drugs, in order to address unmet medical needs in the treatment of serious or life-threatening conditions.

The CAR T-cell therapy “involves modifying a patient’s T-cells to recognise and remove B-cells in the patient’s body,” according to the company’s press release. Kyverna’s KYV-101 is a CD19 specific therapy, targeting the CD19 protein which is involved in various autoimmune diseases.

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Peter Maag, PhD, chief executive officer of Kyverna Therapeutics, commented: “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. This is the second time KYV-101 has received such designation, after obtaining the first one for lupus nephritis earlier this year.”

The company intends to continue to explore other indications for KYV-101.

Betsy Goodfellow

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