Health Canada has granted a Notice of Compliance (NOC) to AbbVie’s Rinvoq (upadacitinib) to treat adult patients diagnosed with chronic autoimmune vasculitis, giant cell arteritis (GCA).
This decision allows for the use of Rinvoq in conjunction with a reduced dose of corticosteroids, as well as a stand-alone therapy after corticosteroids have been phased out.
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GCA is characterised by the inflammation of arteries, including the temporal arteries, and can extend to the aorta and its main branches.
It is more commonly found in individuals of northern European ancestry and affects women at a higher rate than men, stated the company.
The authorisation from the Canadian health authority is based on the Phase III SELECT-GCA trial.
The double-blind, randomised, multicentre SELECT-GCA trial involved 428 GCA patients.
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By GlobalDataIt was designed to assess the efficacy and safety of upadacitinib. The first period of the study, which had its findings reported in April last year, focused on the efficacy of the therapy in conjunction with a 26-week corticosteroid tapering schedule against a placebo combined with a 52-week tapering schedule.
The study also evaluated the therapy’s tolerability and safety. Its second period looked into the efficacy and safety of continuing or discontinuing upadacitinib treatment in maintaining remission for those who had achieved it during the first phase.
AbbVie Canada general manager Rami Fayed said: “This Health Canada approval provides an important option that may allow Canadian patients living with GCA to achieve sustained remission.
“It underscores AbbVie’s commitment to improving outcomes for millions of Canadians living with an autoimmune condition.”
Rinvoq, which was discovered and developed by scientists at AbbVie, is a once-daily oral treatment available in an extended-release tablet form and functions as a Janus kinase inhibitor.
AbbVie has recently entered into an agreement to acquire the lead investigational candidate bretisilocin from Gilgamesh Pharmaceuticals, with the deal potentially reaching $1.2bn, inclusive of an upfront payment and development milestones.
