AbbVie (ABBV) Seeks Rinvoq Nod for Non-Radiographic AS
Zacks Investment Research | Jan 10, 2022 06:23AM ET
AbbVie industry .
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The latest applications seeking approval of Rinvoq for nr-axSpA were based on data from the phase III SELECT-AXIS 2 (Study 2) study in which upadacitinib demonstrated significant improvements in signs and symptoms as well as physical function and disease activity versus placebo. In addition, AbbVie also submitted data from two studies of upadacitinib in adult patients with AS in Europe to gain expanded approval for patients who had an inadequate response to biologic disease-modifying anti-rheumatic drugs (bDMARDs).
In the United States, Rinvoq is approved to treat the rheumatoid arthritis (RA) indication. Last month, the FDA approved Rinvoq for its second indication — active psoriatic arthritis (PsA) in adults who have had an inadequate response or intolerance to one or more TNF blockers. The approval for the PsA indication marked the first new approval for Rinvoq by the FDA after the agency issued a Drug Safety Communication (DSC) in September to include warnings about an increased risk of serious heart-related events, cancer, blood clots, and even death to be added to the label of three JAK inhibitor drugs, including Pfizer’s the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
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