New drug for stiff person syndrome granted designation to speed up development: ‘Thrilled for the community’
Fox News
Kyverna Therapeutics’ new drug, KYV-101, has been designated by the U.S. Food and Drug Administration (FDA) a Regenerative Medicine Advanced Therapy (RMAT), the company announced on Monday.
A drug is eligible for RMAT designation if it is "intended to treat, modify, reverse or cure a serious or life-threatening disease or condition" and if "preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition," according to the FDA’s website. "This RMAT designation means science agrees that fast-tracking this treatment could save lives." Melissa Rudy is senior health editor and a member of the lifestyle team at Fox News Digital. Story tips can be sent to melissa.rudy@fox.com.
One of the benefits of RMAT is that Kyverna will be able to work closely with the FDA to help support accelerated development, review and approval, according to the company.
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