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Ngenla
Sponsor
ARTGs
349990 and 350035
349990 and 350035
Device/Product name
Ngenla
Active Ingredient
Somatrogon
Date of decision
Published
Submission type
New biological entity
ATC codes
Not yet assigned
Decision
Approved
What was the decision based on
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.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
This application was evaluated as part of the Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium, with work-sharing between TGA and Health Canada. Each regulator made independent decisions regarding approval (market authorisation) of the new medicine.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 4 January 2021 |
| First round evaluation completed | 28 May 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 29 July 2021 |
| Second round evaluation completed | 21 September 2021 |
| Delegate's overall benefit-risk assessment | 16 November 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 23 November 2021 |
| Completion of administrative activities and registration on ARTG | 30 November 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 182 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Dose forms
Solution for injection
Strength
24 mg and 60 mg
Other ingredients
Citric acid monohydrate, histidine, metacresol, poloxamer, sodium citrate dihydrate, sodium chloride and water for injections
Containers
Cartridge (prefilled pen)
Pack sizes
One
Routes of administration
Subcutaneous
Dosage
The recommended dose is 0.66 mg/kg body weight administered once weekly by subcutaneous (SC) injection.
Ngenla dosage may be adjusted as necessary, based on growth velocity, body weight and serum insulin-like growth factor 1 (IGF-1) concentration.
For further information refer to the Product Information.
Pregnancy category
B1Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.Studies in animals have not shown evidence of an increased occurrence of fetal damage.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
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.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
- Ngenla (somatrogon) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Ngenla must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The Ngenla European Union (EU)-risk management plan (RMP) (version 0.2, dated 30 August 2021, data lock point (DLP) 21 December 2020), with Australian specific annex (version 0.3, dated 24 September 2021), included with Submission PM-2020-05916-1-5, to be revised to the satisfaction of the TGA, will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP). Module VII-periodic safety update report (rev 1), part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within 90 calendar days of the DLP for that report.
- Laboratory testing and compliance with certified product details
- All batches of Ngenla (somatrogon) supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the certified product details (CPD).
- When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the products. Outcomes of laboratory testing are published biannually in the TGA database of laboratory testing results and periodically in testing reports on the TGA website.
Certified product details
The CPD, as described in Guidance 7: Certified product details of the Australian regulatory guidelines for prescription medicines (ARGPM), in portable document format (PDF), for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
- For all injectable products the PI must be included with the product as a package insert.