AbbVie’s Rinvoq (upadacitinib) Receives the US FDA’s Approval for Moderate to Severe Rheumatoid Arthritis

Shots:

• The US FDA’s approval is based on P-III SELECT program including 5 studies results assessing Rinvoq (15mg) (SELECT-EARLY &-MONOTHERAPY, Rinvoq vs MTX) (SELECT-COMPARE, Rinvoq + MTX vs PBO + MTX) and (SELECT NEXT & -BEYOND, Rinvoq + csDMARDs vs PBO+ csDMARDs) in ~ 4,400 patients with mod. to sev. active RA who have had an inadequate response or intolerance to methotrexate (MTX-IR)
• The P-III five SELECT studies result: met its 1EPs & 2EPs i.e, @12wks. MTX-naive patients achieved ACR50 (52% vs 28%); @14wks. MTX-IR patients achieved ACR20 (68% vs 41%); @12wks. MTX-IR patients achieved ACR20 (71% vs 36%); csDMARD-IR patients achieved ACR20 (64% vs 36%); biologic-IR patients achieved ACR20 (65% vs 28%); inhibition in radiographic progression even without MTX
• Rinvoq is an oral JAK inhibitor being studied for mod. to sev. RA and other immune-mediated diseases. It is under regulatory review in EU, Canada & Japan with its expected availability in the US in late Aug’2019

Click here to­ read full press release/ article | Ref: AbbVie | Image: Daily Herald