Denmark-based pharma company Lundbeck A/S (VIE: LUNB) has announced that it has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its investigational drug amlenetug. The drug is expected to provide a new treatment option for patients with multiple system atrophy (MSA).
Drug Details
Amlenetug is a human monoclonal antibody (mAb) co-developed by Genmab A/S. It recognizes and binds to all major forms of extracellular α-synuclein. The drug is intended to prevent the uptake and inhibit the seeding of aggregation.
Designations and Study Results
Amlenetug previously received Orphan Drug Designation (ODD) for the potential treatment of MSA. It was granted by the US FDA in April 2024 and by the European Medicines Agency (EMA) in May 2021. The drug also received the SAKIGAKE designation from Japan’s Ministry of Health, Labor and Welfare (MHLW) in March 2023. The FDA FTD is supported by results from the Phase II AMULET study. The study showed that amlenetug slowed MSA progression compared to placebo in 61 patients. It also demonstrated a good safety and tolerability profile.-Fineline Info & Tech
