AbbVie submits regulatory applications to FDA and EMA for RINVOQ

▴ abbvie-seeks-approval-new-drug-rinvoq
RINVOQ will be used for the treatment of adults with Active Psoriatic Arthritis

AbbVie , a research-based global biopharmaceutical company, announced that it has submitted applications for a new indication to the U.S. FDA and European Medicines Agency (EMA) for RINVOQ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active psoriatic arthritis.

“Psoriatic arthritis is a complex heterogeneous disease with manifestations across multiple domains, including joints and skin, causing daily pain, fatigue and stiffness,” said Michael Severino, M.D., vice chairman and president, AbbVie. “We look forward to working with regulatory authorities and hope to bring RINVOQ to people living with this debilitating disease as quickly as possible.”

The applications are supported by data from two Phase 3 studies across a broad range of more than 2,000 patients with active psoriatic arthritis.1,2 In both studies, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo.1,2 RINVOQ 15 mg also achieved non-inferiority versus adalimumab in terms of ACR20 response at week 12.1 Patients receiving RINVOQ also experienced greater improvements in physical function (HAQ-DI) and skin symptoms (PASI 75), and a greater proportion achieved minimal disease activity.*,1,2 Overall, the safety profile of RINVOQ in psoriatic arthritis was consistent with previously reported results across the Phase 3 rheumatoid arthritis clinical trial program, with no new significant safety risks detected.

Physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Skin symptoms were measured by a 75 percent improvement in the Psoriasis Area Severity Index (PASI 75). Minimal disease activity is defined as the fulfillment of five of seven outcome measures: Tender joint count ≤1; swollen joint count ≤1; PASI ≤1 or body surface area-psoriasis ≤3 percent; Patient’s Assessment of Pain Numerical Rating Scale (NRS) ≤1.5; Patient Global Assessment-Disease Activity NRS ≤2.0; HAQ-DI score ≤0.5; and Leeds Enthesitis Index ≤1.

About RINVOQ

Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1,2,4-10 In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

In December 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.1,2,4-10 Use of RINVOQ in psoriatic arthritis is not approved and its safety and efficacy have not been established by regulatory authorities.

For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals.

Tags : #Abbvie #FDA #EMA #EuropeanCommission #psoriaticarthritis #Rinvoq

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