Upadacitinib gets TGA approval

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RA patients may soon have access to a selective JAK1 inhibitor that seems to works when other drugs fail

Upadacitinib (Rinvoq) received TGA approval in mid-January for RA, bringing the specialised DMARD one step closer to being available on the Australian market.

AbbVie’s upadacitinib has been approved for treatment of adult patients with moderate to severe active RA who have not responded or are intolerant to DMARDs.

It’s administered as an oral tablet, with a usual dose of 15 mg once daily. It can be used as a monotherapy or in combination with methotrexate or other conventional synthetic DMARDs.

The advent of upadicitinib was important because it provided another option for RA patients when other medications stop working, said Steve Hall, a rheumatologist and adjunct professor at Monash University in Melbourne.

On average, biologics are only effective for about three to four years.

“Consequently, we can expect that patients with RA will move through a number of agents during the course of their lives and the advent of a new agent which is effective when other treatments have failed is very good news for patients and their doctor,” he said.

“The clinical trials establishing its effectiveness are probably the most complete and decisive set of trials ever reported for an agent in RA,” he said.

“The side effect profile is familiar to rheumatologists with an increased risk of infection especially shingles. There seems to be no signal of thromboembolic complications.”

Upadicitinib isn’t marketed in Australia yet, so there’s no price tag associated with the drug here.

“The listed US price more than $50,000 annually but that does not represent the cost for most,” said Professor Hall. “Hopefully this drug will receive a PBS subsidy, which would make it affordable for all in Australia.”

Professor Hall has been a co-author of a number of publications about Upadicitinib and has been on Abbvie advisory boards.

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