Basic Information
Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
Regulatory Information
EMEA/H/C/005367
January 11, 2022
November 11, 2021
5
February 12, 2025
Company Information
Denmark
Tuborg Boulevard 12 2900 Hellerup
Ascendis Pharma Endocrinology Division A/S
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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 \[GHD\])
Overview Summary
Lonapegsomatropin Ascendis Pharma is a medicine that is used to improve growth in children and adolescents who do not produce enough growth hormone (growth hormone deficiency or GHD). The medicine is intended for children and adolescents from 3 up to 18 years of age. GHD is rare, and Lonapegsomatropin Ascendis Pharma was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 October 2019. Further information on the orphan designation can be found here: [ema.europa.eu/medicines/human/orphan-designations/eu3192213](/en/medicines/human/orphan-designations/eu-3-19-2213). Lonapegsomatropin Ascendis Pharma contains the active substance lonapegsomatropin.