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Rinvoq
Published
Product name
Rinvoq
Active ingredient
Upadacitinib
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
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).
How this medicine works
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.
Why the TGA approved or did not approve this medicine
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 Rinvoq was considered favourable for the therapeutic use approved.
Sponsor