AbbVie (ABBV) Tuesday said the U.S. Food and Drug Administration (FDA) has approved Rinvoq for the treatment of adults with giant cell arteritis (GCA).
GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries.
The European Commission had recently granted marketing authorization to Rinvoq for the same indication.
The approvals are supported by results from Phase 3 SELECT-GCA study, which met the primary endpoint of sustained remission. In the study, 46.4% of patients treated with Rinvoq achieved sustained remission compared to those receiving placebo.
This approval marks the ninth approved indication for RINVOQ in the U.S., across rheumatology, gastroenterology, and dermatology.
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