Lundbeck gains FDA fast track designation for MSA therapy amlenetug
Lundbeck has received the US Food and Drug Administration's (FDA) fast track designation for its investigational drug amlenetug, a potential treatment for multiple system atrophy (MSA).
The designation will provide Lundbeck with the possibility of rolling reviews and detailed guidance to streamline the drug development process.
The decision is supported by the outcomes from the Phase II AMULET trial.
Lundbeck research and development head and executive vice-president Johan Luthman stated: 'We are pleased that amlenetug has received fast track designation for the potential treatment of MSA. This is a step forward in our commitment to address significant unmet needs in this devastating disease.'
The drug previously secured the orphan drug designation in the US and from the European Medicines Agency in April 2024 and May 2021 respectively, as well as Japan's Ministry of Health, Labour and Welfare's SAKIGAKE ("pathfinder") designation in March 2023.
A human monoclonal antibody, amlenetug is designed to target and bind to extracellular α-synuclein, aiming to prevent its uptake and block aggregation seeding.
The active Fc region of the drug may also promote the immune-mediated clearance of α-synuclein via microglia-mediated uptake.
Being developed under a joint research and licensing agreement between Lundbeck and Genmab, the drug is being assessed by Lundbeck in the Phase III MASCOT trial to evaluate its safety and efficacy in MSA patients.
The randomised, interventional, double-blind, placebo-controlled, parallel-group, optional open-label extension trial will be conducted in Europe, North America and Asia.
In a strategic move to enhance its presence in the neuro-rare disease sector, Lundbeck completed the acquisition of Longboard Pharmaceuticals in December 2024, securing all its outstanding shares.
"Lundbeck gains FDA fast track designation for MSA therapy amlenetug" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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