FDA Approves AbbVie's RINVOQ To Treat Active Psoriatic Arthritis

AbbVie (ABBV) said that the U.S. Food and Drug Administration has approved RINVOQ (upadacitinib; 15 mg, once daily) for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.

The FDA approval is supported by data from two phase 3 clinical studies where RINVOQ (15 mg, once daily) showed efficacy across multiple measures of disease activity in active psoriatic arthritis with a safety profile consistent with that seen in rheumatoid arthritis.

The company noted that RINVOQ helps to improve joint pain, swelling and stiffness, as well as fatigue, and prevent further joint damage for patients with active Psoriatic arthritis.

The milestone marks the second FDA-approved indication for RINVOQ following rheumatoid arthritis in 2019.

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin. In Psoriatic arthritis, the immune system causes inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue and stiffness in the joints. Psoriatic arthritis affects about 30% of people with psoriasis.

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