Case Study: Rinvoq’s brand Dermatology market expansion strategy

Rinvoq is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Rinvoq is the brand of Abbvie.

Composition

Rinvoq ER is Upadacitinib 15 Mg Tablet, Extended Release Antirheumatic Agents (Biologic DMARDS)

Therapeutic Class

• Rinvoq is a selective and reversible JAK inhibitor
• Janus kinase inhibitors, also known as JAK inhibitors or jakinibs, are a type of medication that functions by inhibiting the activity of one or more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3, TYK2), thereby interfering with the JAK-STAT signaling pathway.

Regulatory Approval

• In August 2019, Rinvoq received US. 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 has 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.

Case Study: USFDA approval of AbbVie’s RINVOQ (upadacitinib)

Strategic Planning for brand Rinvoq

• Phase 3 trials of Rinvoq in atopic dermatitis, psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.
• Use of Rinvoq in atopic dermatitis is not approved and its safety and efficacy have not been established by regulatory authorities.

Among the phase 3 trial Abbvie is focusing aggressively in Dermatology / Atopic Dermatitis (AD). Followings are the strategic planning as far as the Rinvoq in Atopic Dermatitis (AD).

1. Epidemiology, and progression, education, management, comorbidities, and/or humanistic/economic burden of AD.
2. Translational and clinical research to further explore the pathogenesis of AD and other inflammatory skin diseases.
3. Systemic nature of moderate to severe AD.
4. Tools and markers that aid classification/endotype and evaluation of AD.

Clinical Trials

• In October 2020, AbbVie announced that it has submitted applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for Rinvoq (upadacitinib) for the treatment of adults (15 mg and 30 mg, once daily) and adolescents (15 mg, once daily) with moderate to severe atopic dermatitis.
• The atopic dermatitis indication applications to the FDA and EMA are supported by data from three pivotal phase 3 studies. Rinvoq was studied without topical corticosteroids (TCS) in Measure Up 1 and Measure Up 2 and with TCS in AD Up. In all three studies, Rinvoq demonstrated significant improvement in skin clearance and reduction in itch in adults and adolescents with moderate to severe atopic dermatitis compared to placebo.
• Rinvoq met the co-primary endpoints including at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16. Additionally, more patients treated with either dose of upadacitinib experienced a clinically meaningful reduction in itch, defined as improvement in Worst Pruritus Numerical Rating Scale (NRS)=4. The safety profile of Rinvoq was consistent across the three pivotal phase 3 studies in atopic dermatitis. No new safety risks of Rinvoq were observed in these studies compared to the safety profile observed in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis receiving Rinvoq.