AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) as a New Treatment for Moderately to Severely Active Ulcerative Colitis in Adults

September 16, 2021 /BioonBIOON/ -- AbbVie recently announced that it has submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) submittedRegulatory application for Rinvoq (upadacitinib): 45 mg induction dose, 15 mg and 30 mg maintenance doses for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).Rinvoq is an oral, once-daily, selective, reversible JAK inhibitor developed for the treatment of multiple immune-mediated inflammatory diseases.

In the European Union, Rinvoq 15 mg has been approved for four indications.：（1）For the treatment of moderate to severe classRheumatic arthritis(RA) adult patients; (2) for the treatment of adult patients with active psoriatic arthritis (PsA); (3) for the treatment of adult patients with active ankylosing spondylitis (AS); (4) for the treatment of adult and adolescent patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD). In the European Union, Rinvoq 30 mg has been approved for one indication: for the treatment of adult patients under 65 years of age with moderate-to-severe AD.

In the United States, Rinvoq 15 mg is approved for only one indication.: indicated for the treatment of moderate to severe classRheumatic Arthritis(RA) adult patients. Currently, the supplemental application for Rinvoq for the treatment of PsA, AS, and AD is under review by the U.S.FDAof the review.

This application is supported by data from two Phase 3 induction studies (U-ACHIEVE and U-ACCOMPLISH) and one Phase 3 maintenance study (U-ACHIEVE Maintenance).At Week 8 of treatment in the induction study (Rinvoq 45 mg) and at Week 52 of treatment in the maintenance study (Rinvoq 15 mg and 30 mg), a significantly higher proportion of patients in the Rinvoq treatment group achieved the primary endpoint (clinical remission) and all secondary endpoints compared with the placebo group.

In these studies, the safety results of Rinvoq, including the 45 mg dose for induction therapy, were generally consistent with the known safety profile of Rinvoq, with no new important safety risks observed.

AbbVie Chief Scientific Officer and Senior Vice President of Research and Development Tom Hudson stated: “Many patients continue to struggle with symptoms associated with ulcerative colitis (UC), such as fatigue, bowel urgency, bloody diarrhea, and abdominal pain. Upadacitinib has the potential to be an important new treatment option for patients with UC seeking to address these challenging and disruptive symptoms. We look forward to working with regulatory authorities and hope to make upadacitinib available to patients with UC as soon as possible.”

Ulcerative colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes persistent mucosal inflammation, extending from the rectum proximally to varying extents of the colon. The hallmark signs and symptoms of UC include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus, urgency, and fecal incontinence. The disease course of UC varies among patients, ranging from quiescent to chronic refractory disease, and in some cases may necessitate surgery or lead to complications, including cancer or death. The severity of symptoms and the unpredictable nature of the disease course can impose a substantial burden on patients with UC and are often debilitating.

The active pharmaceutical ingredient of Rinvoq is upadacitinib, an oral, selective, and reversible JAK1 inhibitor discovered and developed by AbbVie, which is being developed for the treatment of several immune-mediated inflammatory diseases.JAK1 is a kinase that plays a crucial role in the pathophysiological processes of various inflammatory diseases. Currently, Rinvoq is indicated for the treatment of ulcerative colitis (UC), rheumatoid...Rheumatic ArthritisPhase 3 clinical trials are ongoing for rheumatoid arthritis (RA), psoriatic arthritis (PsA), atopic dermatitis (AD), axial spondyloarthritis (axSpA), Crohn's disease (CD), and giant cell arteritis (GCA).

The industry is highly optimistic about the commercial prospects of Rinvoq. UBS analysts previously predicted that,Rinvoq and Skyrizi, another monoclonal antibody anti-inflammatory drug from AbbVie, will reach peak sales of $11 billion.These two new products will be able to compensate for AbbVie's flagship product Humira (adalimumab) encounteringBiosimilarSales loss caused by the impact.

Humira is the world's first approved anti-TumorTumor necrosis factor-alpha (TNF-α) drug, and also the world's best-selling anti-inflammatory drug, with global sales in 2020 reaching nearly USD 20 billion (USD 19.832 billion). In the European Union, multiple adalimumab biosimilars have already been marketed. In the U.S. market, Humira will faceBiosimilarImpact. (Bioon.com)

Original Source:AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis