Onpattro (patisiran)
OrphanAccelerated assessmentAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- patisiran
- Company
- Alnylam Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Amyloidosis, Familial
- CHMP opinion
- Thu 26 Jul 2018
- EU approval
- Mon 27 Aug 2018
- Designations
- Orphan, Accelerated assessment, Additional monitoring
- Application
- EMEA/H/C/004699
- ATC
- N07
- Official record
- www.ema.europa.eu
Indication
Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.