IntraBio Submits Application to EMA for AQNEURSA Approval for Ataxia-Telangiectasia
IntraBio Inc., a biopharmaceutical company based in Austin, Texas, has submitted a variation application to the European Medicines Agency (EMA) to expand the Marketing Authorization Application for AQNEURSA® (levacetylleucine) to include treatment for Ataxia-Telangiectasia (A-T). A-T is a rare, inherited neurodegenerative disorder affecting coordination, speech, and immune function, with no current approved therapies. The application marks the first regulatory submission to the EMA for an A-T treatment. In the U.S., AQNEURSA has been granted Priority Review by the FDA, with a decision expected by September 19, 2026. 
