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Sogroya

7 March 2022

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

Summary of submission

Submission type
New biological entity
Product name
Sogroya
Active ingredients
Somapacitan
ATC codes
H01AC07
Decision
Approved
Date of decision
14 February 2022
Date of entry onto ARTG
21 February 2022
Original publication date
7 March 2022
ARTG numbers
363895
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
Sponsor
Novo Nordisk Pharmaceuticals Pty Ltd
Sponsor address
Level 10, 118 Mount Street, North Sydney NSW 2060
Dose forms
Solution for injection
Strength
10 mg/1.5 mL
Other ingredients
Histidine, mannitol, poloxamer, phenol, hydrochloric acid, sodium hydroxide and water for injections
Containers
Prefilled pen (cartridge)
Pack sizes
1 and 5
Routes of administration
Subcutaneous
Dosage

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

B1

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.

What was approved?

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).

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  • 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.

Quality

  • 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.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.