Lundbeck’s Amlenetug for MSA Receives FDA Fast Track Designation

The FDA has granted Fast Track Designation to Lundbeck’s investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy (MSA). Lundbeck has recently initiated MASCOT, a phase III trial to assess efficacy and safety of amlenetug for the treatment of MSA.

H. Lundbeck A/S (Lundbeck) announced that amlenetug has received Fast Track designation from the United States (US) Food and Drug Administration (FDA).

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 Designation features, including rolling potential reviews, and intensive FDA guidance on an efficient drug development program.

“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,” said Johan Luthman, EVP and Head of Research & Development at Lundbeck.

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. The FDA grants ODD to investigational therapies intended for treatment, prevention, or diagnosis of a rare disease or condition that affects fewer than 200,000 people in the U.S. at the time of designation.