Tegsedi (inotersen)
OrphanAccelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- inotersen
- Company
- Akcea Therapeutics Ireland Limited
- Status
- Authorised
- Therapeutic area
- Amyloidosis
- CHMP opinion
- Wed 30 May 2018
- EU approval
- Fri 06 Jul 2018
- Designations
- Orphan, Accelerated assessment
- Application
- EMEA/H/C/004782
- ATC
- N07
- Official record
- www.ema.europa.eu
Indication
Treatment of stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).
Regulatory milestones
Thu 12 Nov 2026🇪🇺 EU shortage
Tegsedi: shortage ongoing
Solution for injection in pre-filled syringe; Alternatives available: Yes · source
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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.