Annexon Submits Tanruprubart Marketing Authorization Application to the European Medicines Agency for Guillain-Barré Syndrome

Core Insights - Annexon, Inc. has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for tanruprubart, a potential first targeted fast-acting therapy for Guillain-Barré syndrome (GBS) [1][2] - The company plans to submit a Biologics License Application (BLA) to the FDA in 2026, with data from the ongoing FORWARD trial [1][3] Company Overview - Annexon is focused on developing targeted immunotherapies for neuroinflammatory diseases affecting nearly 10 million people globally [1][7] - The company aims to provide meaningful functional benefits and alter the course of diseases by stopping classical complement-driven neuroinflammation [7] Product Details - Tanruprubart is a first-in-class antibody designed to block classical complement-driven inflammation, showing rapid effects in stopping early nerve damage in GBS patients [2][4] - The therapy has received Orphan Drug designations from both the FDA and EMA, indicating a recognized need for improved treatments [2][5] Clinical Data - The MAA submission included comprehensive data demonstrating that tanruprubart allows patients to recover faster and more completely compared to existing treatments [3][4] - The ongoing FORWARD study aims to support a broad label for both pediatric and adult patients, expanding the use of tanruprubart across different geographies [3][4] Disease Context - GBS is a rare neuromuscular emergency affecting over 150,000 people annually worldwide, with no approved treatments in the U.S. [2][6] - The disease leads to significant morbidity and has a multi-billion-dollar annual economic cost to the U.S. healthcare system [6]