Rozebalamin mecobalamin

Drug Class

Ultrahigh-dose vitamin B12 analog / Neuroprotective agent

Mechanism

Ultrahigh-dose mecobalamin acts as a neuroprotectant by promoting axonal regeneration, myelination, and reducing neurotoxic homocysteine levels in patients with ALS.

Approved Indication

Slowing the progression of functional impairment in patients with early-stage amyotrophic lateral sclerosis (ALS), per its PMDA approval.

What This Means For Patients

Rozebalamin is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• PMDA — Approved (2024) — Sources

Pivotal Clinical Evidence

• JETALS — Oki et al., JAMA Neurol 2022 (NCT03548311) — Sources

Sources

• https://www.eisai.com/news/2024/news202466.html
• https://www.pmda.go.jp/
• https://doi.org/10.1001/jamaneurol.2022.0901