FDA grants RMAT designation to myasthenia gravis therapeutic

The FDA has granted Regenerative Medicine Advanced Therapy designation to an autologous, fully human CD19 chimeric antigen receptor T-cell therapy candidate, to treat those with progressive myasthenia gravis.

According to a press release from manufacturer Kyverna Therapeutics Inc., KYV-101 is currently being evaluated in open-label, phase 1/2 and phase 2 clinical trials in the United States and Germany for potential applications in rheumatology and neurology.

In July, the FDA granted similar status to KYV-101 to treat individuals with refractory stiff person syndrome.

“We are very happy with the constructive scientific rapport established between Kyverna and the FDA,” Kyverna CEO Peter Maag, PhD, said in the release. “We believe the RMAT designation may ultimately add to our rigorous approach to KYV-101 development in the hope of benefitting the most deserving patients.”