“We are pleased that amlenetug has received Fast Track Designation for the potential treatment of Multiple System Atrophy. This is a step forward in our commitment to address significant unmet needs in this devastating disease,” says Johan Luthman, EVP and Head of Research & Development at Lundbeck.

Lundbeck has recently initiated MASCOT, a phase III trial to assess efficacy and safety of amlenetug for the treatment of MSA.

The AMULET trial

This designation is based on the outcome of AMULET, the phase II trial, which was presented in March 2024.

Amlenetug has also been granted Orphan Drug Designation (ODD) for the potential treatment of MSA by US FDA in April 2024 and by EMA in May 2021 and the SAKIGAKE designation from the Ministry of Health, Labor and Welfare (MHLW) in Japan in March 2023.