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Lundbeck’s Potential Treatment for Multiple System Atrophy Granted Fast Track Designation

Expedites the development and review process for amlenetug.

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By: Charlie Sternberg

Associate Editor

The FDA has granted Fast Track Designation to Lundbeck’s investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy (MSA). This designation is based on the outcome of AMULET, the phase II trial, which was presented in March 2024 at the International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD) in Lisbon, Portugal. With this designation, Lundbeck will benefit from all FDA Fast Track D...

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