Skytrofa (previously Lonapegsomatropin Ascendis Pharma) (lonapegsomatropin)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- lonapegsomatropin
- Company
- Ascendis Pharma Endocrinology Division A/S
- Status
- Authorised
- Therapeutic area
- Growth and Development
- CHMP opinion
- Thu 11 Nov 2021
- EU approval
- Tue 11 Jan 2022
- Designations
- Orphan
- Application
- EMEA/H/C/005367
- ATC
- H01AC09
- Official record
- www.ema.europa.eu
Indication
Growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD])
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.