Growth Hormone Deficiency in Children
Drug: Somapacitan / Drug: Norditropin®
Phase 3
Estimated Study Start Date : May 20, 2019
Estimated Primary Completion Date : June 5, 2021
Estimated Study Completion Date : July 4, 2024
https://clinicaltrials.gov/ct2/show/NCT03811535
On 24 August 2018, orphan designation (EU/3/18/2068) was granted by the European Commission to Novo Nordisk A/S, Denmark, for somapacitan for the treatment of growth hormone deficiency.
https://www.ema.europa.eu/en/medicines/human/...esignations/eu3182068
Furthermore, we completed the pediatric Phase 2 extension of the REAL3 trial with a long-acting growth hormone somapacitan. The endpoint for the REAL3 extension was to evaluate the effect of different dose regimens for once-weekly somapacitan after one full year of treatment compared to daily Norditropin. The trial confirmed a dose-dependent increase in growth velocity, and the observed safety profile of somapacitan was similar to that of Norditropin.
Novo Nordisk is now preparing for the Phase 3 program in growth hormone deficient children, as well as for a Phase 2 trial in children born small for gestational age. In addition, we are preparing for a regulatory submission of somapacitan for the adult growth hormone deficiency indication in the second half of this year.
https://www.fool.com/earnings/call-transcripts/...onference-call.aspx
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