AbbVie Submits Applications For Upadacitinib In Non-Radiographic Axial Spondyloarthritis To FDA

AbbVie (ABBV) said Friday that it has submitted applications seeking approvals for upadacitinib (RINVOQ, 15 mg once daily) to the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

Axial spondyloarthritis is a chronic inflammatory disease that affects the spine, causing back pain, limited mobility, and structural damage.

AbbVie said it has also submitted results from two studies of upadacitinib in adult patients with ankylosing spondylitis (AS) to request label enhancements in the European Union.

RINVOQ is approved for use in active psoriatic arthritis (PsA), moderate to severe active rheumatoid arthritis (RA), moderate to severe atopic dermatitis (AD) and active AS in the EU, and for PsA and RA in the U.S.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Asweets Global Inc. is recalling about 2,000 units of Wonder & Wise Activity Tables for potential risk of choking hazard to young children, a statement by the U.S. Consumer Product Safety Commission (CPSC) showed. The company said the screws of the tables can become loose and/or detach from the xylophone component of the activity tables to pose a choking hazard to young children. Chinese e-commerce giant Alibaba Group Holdings Ltd. (BABA) reported Thursday a net loss for the fourth quarter that sharply widened from last year, despite 9 percent growth in revenues, hurt by a decreases in the market prices of our equity investments in publicly-traded companies. Omni-channel fashion retailer Macy's, Inc. (M) reported Thursday a first-quarter net income of $286 million or $0.98 per share, sharply higher than $103 million or $0.32 per share in the prior-year quarter. Excluding items, adjusted net income for the quarter was $315 million or $1.08 per share, compared...
Follow RTT