Rukobia
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 July 2020 |
| First round evaluation completed | 12 March 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 12 May 2021 |
| Second round evaluation completed | 18 May 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 4 May 2021 |
| Sponsor's pre-Advisory Committee response | 17 May 2021 |
| Advisory Committee meeting | 3 and 4 June 2021 |
| Registration decision (Outcome) | 9 July 2021 |
| Completion of administrative activities and registration on ARTG | 14 July 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 191 |
*Statutory timeframe for standard applications is 255 working days
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Therapy should be initiated by a physician experienced in the management of human immunodeficiency virus (HIV) infection.
Adults
The recommended dosage of fostemsavir is 600 mg orally twice daily. For further information refer to the Product Information.
Rukobia (fostemsavir trometamol) was approved for the following therapeutic use:
Rukobia is indicated in combination with other antiretroviral agents for the treatment of heavily treatment-experienced adults with multidrug-resistant human immunodeficiency virus-1 (HIV-1) infection for whom it is otherwise not possible to construct a suppressive antiviral regimen due to resistance, intolerance or safety considerations (see Section 5.1 Pharmacodynamic properties, clinical trials).
- Rukobia (fostemsavir) is to be included in the Black Triangle Scheme. The Product Information and Consumer Medicine Information for Rukobia 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 Rukobia European Union (EU) - Risk Management Plan (RMP) (version 1.0, dated 15 January 2021, data lock point 6 September 2019), with Australian specific annex (version 1.2, dated April 2021), included with submission PM-2020-02898-1-2, 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.