Gene therapy AAV-GAD wins RMAT designation for Parkinson’s disease
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Gene therapy AAV-GAD wins RMAT designation for Parkinson’s disease
The U.S. Food and Drug Administrated (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) status to AAV-GAD, MeiraGTx’s gene therapy for Parkinson’s disease, the company has announced. The designation was granted based on data from three clinical studies showing the treatment eased motor symptoms and improved the quality of life of people with Parkinson’s. The company is now in regulatory discussions to initiate a Phase 3 study this y…
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