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EMA Product

Onpattro

Product approved by European Medicines Agency (EU)

Basic Information

Onpattro

Regulatory Information

EMEA/H/C/004699

Authorised

August 27, 2018

July 26, 2018

14

March 25, 2025

Company Information

Netherlands

Antonio Vivaldistraat 150 1083 HP Amsterdam

Alnylam Netherlands BV

Drug Classification

Orphan MedicineAdditional MonitoringAccelerated Assessment

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Overview Summary

Onpattro is a medicine used to treat nerve damage caused by hereditary transthyretin (hATTR) amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves. Onpattro is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient is able to walk unaided, and stage 2, when the patient can still walk but needs help). hATTR amyloidosis is rare, and Onpattro was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 April 2011. Onpattro contains the active substance patisiran.

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