AGAMREE vamorolone

Drug Class

Dissociative corticosteroid

Mechanism

Vamorolone binds to glucocorticoid receptors to exert anti-inflammatory effects while reducing receptor dissociation-associated side effects.

Approved Indication

Treatment of Duchenne muscular dystrophy (DMD) in patients aged 2 years and older (FDA) or 4 years and older (NMPA).

What This Means For Patients

AGAMREE 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

• FDA — Approved (2023) — Sources
• EMA — Approved (2023) — Sources
• NMPA — Approved (2024) — Sources

Pivotal Clinical Evidence

• VISION-DMD — Guglieri et al., JAMA Neurol 2022 (NCT03439670) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215239s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/agamree
• https://doi.org/10.1001/jamaneurol.2022.2480