Upadacitinib ER is under clinical development by AbbVie and currently in Phase III for Systemic Lupus Erythematosus. According to GlobalData, Phase III drugs for Systemic Lupus Erythematosus have a 29% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Upadacitinib ER’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Upadacitinib ER overview

Upadacitinib (Rinvoq, Rim-Voq) is an antineoplastic drug, acts as immunosuppressive agent. It is formulated as extended release tablets, coated tablets and film coated tablets for oral route of administration. Rinvoq is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis  who have had an inadequate response or intolerance to methotrexate and is indicated as monotherapy or in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs), indicated for active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs and also indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Rinvoq is indicated for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment (e.g., steroid or biologic) or when use of those therapies is inadvisable. Rinvoq is indicated for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Rinvoq is indicated for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Rinvoq is indicated for the treatment of ankylosing spondylitis, which is inadequately effective with existing treatments in adults. Rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

Upadacitinib tartrate (ABT-494) is under development for the treatment of systemic idiopathic juvenile arthritis, alopecia areata, non-segmental vitiligo, moderate to severe hidradenitis suppurativa, moderately to severely active systemic lupus erythematosus, moderately to severely active rheumatoid arthritis (RA), psoriatic arthritis, Takayasu arteritis, ulcerative colitis, spondyloarthritis, juvenile idiopathic arthritis, oligoarticular idiopathic juvenile arthritis, polyarticular juvenile idiopathic arthritis, Crohn's disease in adults and pediatric patients, giant cell arteritis and ankylosing spondylitis. ABT-494 is administered through oral route as a tablet. The drug candidate targets JAK 1. It was also under development for the treatment of moderate to severe atopic dermatitis.

AbbVie overview

AbbVie is a specialty biopharmaceutical company, which discovers, develops, manufactures, and commercializes drugs for the treatment of chronic and complex diseases. Its drugs are indicated for the treatment of metabolic and rheumatological diseases, neurological disorders, skin diseases, rheumatoid arthritis, pain related to endometriosis, pediatric Crohn’s disease, cancer, and other serious health conditions. AbbVie is also advancing its pipeline programs for the treatment of Crohn’s disease, Parkinson’s disease, neurological disorders, aesthetics, and other autoimmune diseases. The company markets its products directly to wholesalers, distributors, healthcare facilities, government agencies, specialty pharmacies, and independent retailers. The company has operations in the Americas, Asia-Pacific, Europe, the Middle East and Africa. AbbVie is headquartered in North Chicago, Illinois, the US.

For a complete picture of Upadacitinib ER’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 22 April 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.