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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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