The Ministry of Health, Labor, and Welfare (MHLW) in Japan has granted Orphan Drug Designation (ODD) to Lundbeck's investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy (MSA).

H. Lundbeck A/S (Lundbeck) announced that amlenetug has received Orphan Drug Designation (ODD) from the MHLW in Japan.

The ODD in Japan adds to other important designations: the SAKIGAKE designation by Japan's MHLW in March 2023, the Orphan Drug Designation (ODD) by the US FDA in April 2024, and by EMA in May 2021.

"We are pleased to receive Orphan Drug Designation for amlenetug in Japan. This designation highlights the potential of amlenetug as a treatment option for people living with Multiple System Atrophy. We are hopeful of the potential for amlenetug to slow the clinical progression of this devastating disease and look forward to advancing its development through the MASCOT trial", said 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 in the treatment of MSA.

The MASCOT trial will open for enrollment in North America, Europe, Asia and Australia.