Danish biopharmaceutical company H. Lundbeck A/S (CPH:HLUN-A) announced on Wednesday that it has received Fast Track designation from the US Food and Drug Administration (FDA) for amlenetug, an investigational treatment for multiple system atrophy (MSA).

This designation is based on results from the AMULET phase II trial, presented in March 2024 at the International Conference on Alzheimer's and Parkinson's Diseases.

Lundbeck has recently initiated MASCOT, a phase III trial to evaluate amlenetug's efficacy and safety in MSA. Fast Track designation enables the company to engage in more frequent interactions with the FDA and benefit from rolling reviews to expedite the drug's development.

Amlenetug has also received Orphan Drug Designation from the FDA (April 2024) and the European Medicines Agency (May 2021), and the SAKIGAKE designation from Japan's Ministry of Health, Labor and Welfare (March 2023).

Developed under a joint research and licensing agreement between Lundbeck and Danish biotechnology company Genmab A/S (CPH:GMAB), amlenetug is a human monoclonal antibody designed to bind to extracellular α-synuclein, potentially inhibiting its aggregation.