Rinvoq Approved to Treat Rheumatoid Arthritis
August 16, 2019 – The U.S. FDA has approved Rinvoq™ (upadacitinib), manufactured by AbbVie, to treat moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to methotrexate (MTX-IR).
An estimated 1.5 million individuals in the United States have RA, an autoimmune disease in which the body’s immune system attacks the joints. This leads to inflammation, swelling, and pain. The inflammation can cause permanent damage to the cartilage and bones of the joints, sometimes early in the course of disease, which leads to a loss of mobility. Early diagnosis and aggressive treatment can help control the effects of RA.
In clinical studies, patients who received Rinvoq either alone or in combination with methotrexate or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) showed significant improvement over those who received methotrexate or csDMARDs alone, methotrexate plus a placebo, or csDMARDs plus a placebo. Recommended dosing is 15mg once daily taken either as a monotherapy or in combination with methotrexate or other non-biologic DMARDs. A black box warning cautions that there is a risk of serious infections, malignancy, and thrombosis (blood cloths) associated with the use of Rinvoq.
AbbVie has launched the product at a list price of $59,000 per year.