Takhzyro (lanadelumab)
OrphanAccelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- lanadelumab
- Company
- Takeda Pharmaceuticals International AG Ireland Branch
- Status
- Authorised
- Therapeutic area
- Angioedemas, Hereditary
- CHMP opinion
- Thu 18 Oct 2018
- EU approval
- Thu 22 Nov 2018
- Designations
- Orphan, Accelerated assessment
- Application
- EMEA/H/C/004806
- ATC
- B06AC05
- Official record
- www.ema.europa.eu
Indication
Takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older.
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.