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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 chemical entity
|Product name|| |
|Active ingredients|| |
|ATC codes|| |
|Date of decision|| |
17 January 2020
|Date of entry onto ARTG|| |
17 January 2020
|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
AbbVie Pty Ltd
|Sponsor address|| |
241 O'Riordan St, Mascot NSW 2020
|Dose forms|| |
Modified release tablet
|Other ingredients|| |
Each tablet contains the following inactive ingredients: microcrystalline cellulose, hypromellose, mannitol, tartaric acid, colloidal anhydrous silica, and magnesium stearate.
Film coating contains polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), ferrosoferric oxide (E172) and iron oxide red (E172).
|Pack sizes|| |
7 tablets (starter pack) and 28 tablets (monthly pack)
|Routes of administration|| |
Therapy with Rinvoq should be initiated and monitored by a rheumatologist or specialist physician with expertise in the management of rheumatoid arthritis.
The recommended oral dose of Rinvoq is 15 mg once daily with or without food.
Rinvoq should not be initiated in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1000 cells/mm3 or who have haemoglobin levels less than 8 g/dL (see Product Information Sections 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and 4.8 ADVERSE EFFECTS).
Rinvoq may be used as monotherapy or in combination with methotrexate or other csDMARDs.
Combination with other JAK inhibitors or potent immunosuppressants has not been studied and is not recommended.
For further information refer to the Product Information.
|Pregnancy category|| |
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.
Rinvoq (upadacitinib hemihydrate) was approved for the following therapeutic use:
Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs).
Rinvoq may be used as monotherapy or in combination with methotrexate or other conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).
Janus Kinases (JAKs) are important intracellular enzymes that transmit cytokine or growth factor signals involved in a broad range of cellular processes including inflammatory responses, haematopoiesis and immune surveillance. The JAK family of enzymes contains four members, JAK1, JAK2, JAK3 and TYK2 which work in pairs to phosphorylate and activate signal transducers and activators of transcription (STATs). This phosphorylation, in turn, modulates gene expression and cellular function. JAK1 is important in inflammatory cytokine signals while JAK2 is important for red blood cell maturation and JAK3 signals play a role in immune surveillance and lymphocyte function.
Upadacitinib is a selective and reversible inhibitor of JAK1. Upadacitinib more potently inhibits JAK1 compared to JAK2 and JAK3. In cellular potency assays that correlated with the in vivo pharmacodynamic responses, upadacitinib demonstrated 33 to 197 fold greater selectivity for JAK1-associated signalling over JAK2-JAK2 signalling. In enzyme assays, upadacitinib had > 50 fold selectivity for JAK1 over JAK3.
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||31 January 2019|
|First round evaluation completed||1 August 2019|
|Sponsor provides responses on questions raised in first round evaluation||30 August 2019|
|Second round evaluation completed||18 October 2019|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||31 October 2019|
|Sponsor's pre-Advisory Committee response||13 November 2019|
|Advisory Committee meeting||6 December 2019|
|Registration decision (Outcome)||17 January 2020|
|Completion of administrative activities and registration on ARTG||17 January 2020|
|Number of working days from submission dossier acceptance to registration decision*||221|
*Statutory timeframe for standard applications is 255 working days
- Rinvoq (upadacitinib) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Rinvoq 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 Rinvoq European Union-Risk Management Plan (EU-RMP) (version 1.6, dated October 2019, data lock point 13 September 2018), with Australian Specific Annex (version 1.4, dated November 2019), included with submission PM-2018-05603-1-3, 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 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.
- The final study reports for the following studies must be submitted to the TGA, as soon as possible after completion, for evaluation as Category 1 submission(s):