You are here
The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.
Australian prescription medicine decision summary
|Submission type|| |
New biological entity
|Product name|| |
|Active ingredients|| |
|ATC codes|| |
|Date of decision|| |
14 February 2022
|Date of entry onto ARTG|| |
21 February 2022
|Original publication date|| |
7 March 2022
|ARTG numbers|| |
|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
Novo Nordisk Pharmaceuticals Pty Ltd
|Sponsor address|| |
Level 10, 118 Mount Street, North Sydney NSW 2060
|Dose forms|| |
Solution for injection
10 mg/1.5 mL
|Other ingredients|| |
Histidine, mannitol, poloxamer, phenol, hydrochloric acid, sodium hydroxide and water for injections
Prefilled pen (cartridge)
|Pack sizes|| |
1 and 5
|Routes of administration|| |
Somapacitan should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of adult patients with growth hormone deficiency (for example, endocrinologists).
Dosage is based on multiple factors, including the age of the patient and whether the patient has been switched from daily growth hormone medicinal products. The somapacitan dose must be individually adjusted for each patient.
For further information refer to the Product Information.
|Pregnancy category|| |
Drugs 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.
Sogroya (somapacitan) was approved for the following therapeutic use:
Sogroya is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD).
Somapacitan is a long‑acting recombinant human growth hormone derivative. It consists of 191 amino acids similar to endogenous human growth hormone, with a single substitution in the amino acid backbone (L101C) to which an albumin binding moiety has been attached. The albumin binding moiety (side‑chain) consists of a fatty acid moiety and a hydrophilic spacer attached to position 101 of the protein.
The mechanism of action of somapacitan is either directly via the growth hormone (GH)‑receptor and/or indirectly via insulin like growth factor‑1 (IGF-I) produced in tissues throughout the body, but predominantly by the liver. When growth hormone deficiency is treated with somapacitan, a normalisation of body composition (that is, decreased body fat mass, increased lean body mass) and of metabolic action is achieved.
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 Sogroya was considered favourable for the therapeutic use approved.
The following table summarises the key steps and dates for this comparable overseas regulator approach B (COR-B) application.
|Submission dossier accepted and first round evaluation commenced||1 June 2021|
|First round evaluation completed||25 August 2021|
|Sponsor provides responses on questions raised in first round evaluation||25 October 2021|
|Second round evaluation completed||26 November 2021|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||14 January 2022|
|Sponsor's pre-Advisory Committee response||Not applicable|
|Advisory Committee meeting||Not applicable|
|Registration decision (Outcome)||14 February 2022|
|Completion of administrative activities and registration on ARTG||21 February 2022|
|Number of working days from submission dossier acceptance to registration decision*||133|
*The COR-B process has a 175 working day evaluation and decision timeframe.
- Sogroya (somapacitan) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Sogroya 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 Sogroya European Union (EU)‑risk management plan (RMP) (version 1.0, dated 7 April 2021, data lock point 31 March 2019), with Australian specific annex (version 0.3, dated 20 December 2021), included with Submission PM‑2021‑01699‑1‑5, and any subsequent revisions, as agreed with 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).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs 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 (revision 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
- Laboratory testing and compliance with Certified Product Details (CPD)
- All batches of Sogroya (somapacitan) 6.7 mg/mL solution for injection prefilled pen 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 product. 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 Certified Product Details (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.