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Intrarosa
Sponsor
Device/Product name
Intrarosa
Active Ingredient
Prasterone
Date of decision
Published
Submission type
New Chemical Entity
ATC codes
G03XX01
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 Intrarosa 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.
|
Description |
Date |
|---|---|
|
Submission dossier accepted and first round evaluation commenced |
31 August 2022 |
|
First round evaluation completed |
18 January 2023 |
|
Sponsor provides responses on questions raised in first round evaluation |
17 March 2023 |
|
Second round evaluation completed |
28 March 2023 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
13 June 2023 |
|
Sponsor’s pre-Advisory Committee response |
Not applicable |
|
Advisory Committee meeting |
Not applicable |
|
Registration decision (Outcome) |
15 June 2023 |
|
Completion of administrative activities and registration on ARTG |
16 June 2023 |
|
Number of working days from submission dossier acceptance to registration decision* |
150 |
*Statutory timeframe for standard applications is 255 working days.
Date of entry onto ARTG
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
Pessary.
Strength
6.5 mg.
Other ingredients
Hard fat.
Containers
Blister Pack.
Pack sizes
28 pessaries (Blister Pack).
Routes of administration
Vaginal.
Dosage
One pessary is administered once a day at bedtime.
For further information refer to the Product Information.
Pregnancy category
D
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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.
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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
Intrarosa (prasterone) was approved for the following therapeutic use:
Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
What is this medicine and how does it work
Prasterone is biochemically and biologically identical to endogenous human dehydroepiandrosterone (DHEA), a precursor steroid with no or little pharmacological activity itself that is converted into oestrogens and androgens. These metabolites are formed from prasterone activate oestrogen and androgen receptors. Intrarosa is thus different from the oestrogens preparations since it also delivers androgen metabolites.
An increase in the number of superficial and intermediate cells and decrease in the number of parabasal cells in the vaginal mucosa is noted. In addition, the vaginal pH decreased towards the normal range, thus facilitating the growth of the normal bacterial flora.
An increase in the number of superficial and intermediate cells and decrease in the number of parabasal cells in the vaginal mucosa is noted. In addition, the vaginal pH decreased towards the normal range, thus facilitating the growth of the normal bacterial flora.
What post-market commitments will the sponsor undertake
- Intrarosa (prasterone) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Intrarosa 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 Intrarosa EU [European Union]-Risk Management Plan (RMP) (version 1.8, date 29 March 2023; DLP [data lock point] 28 March 2023), with Australian Specific Annex (version 1.0, dated 9 February 2023), included with submission PM-2022-02509-1-5, 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 (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 ninety calendar days of the data lock point for that report.