United States-based AbbVie (NYSE: ABBV) announced on Friday that it has received approval from the United States Food and Drug Administration (FDA) for RINVOQ(R) (upadacitinib; 15 mg, once daily), intended to treat adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) blockers.

The product received approval based on the efficacy and safety data from a Phase three SELECT-AXIS 2 clinical trial (Study 1) assessing RINVOQ in patients displaying inadequate response or intolerance to one or two biologic disease-modifying anti-rheumatic drugs (bDMARDs), and the Phase 2/3 SELECT-AXIS one clinical trial assessing RINVOQ in patients who were naive to bDMARDs and had an inadequate response or intolerance to at least two nonsteroidal anti-inflammatory drugs (NSAIDs).

Atul Deodhar MD, professor of medicine and medical director of the Rheumatology Clinics for the Division of Arthritis and Rheumatic Diseases at Oregon Health & Science University, and investigator of the SELECT-AXIS 1 trial, said: "Many patients with ankylosing spondylitis do not achieve disease control with current biologic therapies and additional treatments are needed to help relieve the signs and symptoms of this disease. With today's FDA approval, patients who do not respond to a TNF inhibitor have an additional oral treatment option, in partnership with their rheumatologist, to help take control of this disease."