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EMA Product

Amvuttra

Product approved by European Medicines Agency (EU)

Basic Information

Amvuttra

Regulatory Information

EMEA/H/C/005852

Authorised

September 15, 2022

July 21, 2022

4

January 17, 2024

Company Information

the netherlands

Antonio Vivaldistraat 150 Cross Towers, 20th floor 1083 HP Amsterdam

Alnylam Netherlands BV

Drug Classification

Orphan MedicineAdditional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Overview Summary

Amvuttra is a medicine used to treat polyneuropathy (nerve damage) caused by hereditary transthyretin-mediated (hATTR) amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves. Amvuttra is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient has weakness in the legs but is able to walk unaided, and stage 2, when the patient can still walk but needs help). hATTR amyloidosis is rare, and Amvuttra was designated an ‘ [orphan medicine](/en/node/43119)’ (a medicine used in rare diseases) on 25 May 2018. Further information on the orphan designation can be found [here](/en/medicines/human/orphan-designations/eu-3-18-2026). Amvuttra contains the active substance vutrisiran.

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