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Ngenla
Published
Product name
Ngenla
Active ingredient
Somatrogon
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Ngenla (somatrogon) was approved for the following therapeutic use:
Ngenla is indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.
How this medicine works
Somatrogon is a glycoprotein produced in Chinese hamster ovary (CHO) cells by recombinant deoxyribonucleic acid (DNA) technology. It is comprised of the amino acid sequence of human growth hormone (hGH) with one copy of the of carboxyl terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the amino terminus (N-terminus) and two copies of CTP (in tandem) at the C‑terminus. The glycosylation and CTP domains account for the half-life of somatrogon, which allows for weekly dosing. Somatrogon binds to the growth hormone (GH) receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. Consistent with GH signalling, somatrogon binding leads to activation of the signal transducer and activator of transcription 5b (STAT5b) signalling pathway and increases the serum concentration of insulin like growth factor‑1 (IGF-1). IGF-1 was found to increase in a dose dependent manner during treatment with somatrogon partially mediating the clinical effect. As a result, GH and IGF-1 stimulate metabolic changes, linear growth, and enhance growth velocity in paediatric patients with GH deficiency.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Ngenla was considered favourable for the therapeutic use approved.
Sponsor