Uvadex
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 28 September 2018 |
| First round evaluation completed | 1 March 2019 |
| Sponsor provides responses on questions raised in first round evaluation | 6 May 2019 |
| Second round evaluation completed | 20 June 2019 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 2 July 2019 |
| Sponsor's pre-Advisory Committee response | 15 July 2019 |
| Advisory Committee meeting | 1-2 August 2019 |
| Registration decision (Outcome) | 13 September 2019 |
| Completion of administrative activities and registration on ARTG | 16 September 2019 |
| Number of working days from submission dossier acceptance to registration decision* | 184 |
*Statutory timeframe for standard applications is 255 working days
Three extracorporeal photopheresis (ECP) treatments in the first week then two ECP treatments per week for at least 12 weeks, or as clinically indicated.
For further information refer to the Product Information.
Uvadex (methoxsalen) was approved for the following therapeutic use:
Uvadex (methoxsalen) is indicated for extracorporeal administration with the Therakos Cellex Photopheresis System for the treatment of steroid-refractory and steroid-intolerant chronic graft versus host disease (cGVHD) in adults following allogeneic HSC transplantation.
The following specific conditions of registration apply to this approval:
- Uvadex (methoxsalen) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Uvadex 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 methoxsalen Australian-Risk Management Plan (Aus-RMP) (version 3.0, dated 15 April 2019, data lock point 25 February 2018), included with submission PM-2018-03515-1-2, 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).
As agreed between the TGA and the supplier who is the recipient of the approval, annual PSURs with the data lock point of 25th February are to be provided until the period covered by such reports is not less than three years from the date of this 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 and submitted to the TGA within ninety calendar days of the data lock point for that report.
- For all injectable products the Product Information must be included with the product as a package insert.