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In three phase 3 clinical studies, Rinvoq significantly improved clinical, endoscopic, and histological results compared with placebo
.
Ulcerative colitis (UC, image source: healthjade.
com)
September 16, 2021/Bio Valley BIOON/ --AbbVie recently announced that it has submitted Rinvoq (upadacitinib, upada) to the U.
S.
Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Tinib) regulatory application: 45mg induction dose, 15mg and 30mg maintenance dose, for the treatment of moderate to severe adult patients with active ulcerative colitis (UC)
.
Rinvoq is an oral, once-daily, selective and reversible JAK inhibitor developed to treat a variety of immune-mediated inflammatory diseases
In the European Union, Rinvoq 15mg has been approved for 4 indications: (1) for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA); (2) for the treatment of active psoriatic arthritis (PsA) Adult patients; (3) for the treatment of adult patients with active ankylosing spondylitis (AS); (4) for the treatment of adult patients with moderate to severe atopic dermatitis (AD) and adolescent patients 12 years and older
.
In the European Union, Rinvoq 30mg has been approved for 1 indication: it is used to treat adults with moderate to severe AD under 65 years of age
In the United States, Rinvoq 15mg is only approved for 1 indication: it is used to treat adult patients with moderate to severe rheumatoid arthritis (RA)
.
Currently, Rinvoq's supplementary application for the treatment of PsA, AS, and AD is under review by the US FDA
This application is supported by data from 2 phase 3 induction studies (U-ACHIEVE, U-ACCOMPLISH) and 1 phase 3 maintenance study (U-ACHIEVE Maintenance)
.
In the induction study (Rinvoq 45mg) treatment week 8 and the maintenance study (Rinvoq 15mg and 30mg) treatment week 52, compared with the placebo group, the proportion of patients in the Rinvoq treatment group who reached the primary endpoint (clinical remission) and all secondary endpoints Significantly higher
In these studies, the safety results of Rinvoq, including the 45mg dose as an induction therapy, are generally consistent with the known safety characteristics of Rinvoq, and no new important safety risks have been observed
.
Tom Hudson, AbbVie’s Chief Scientific Officer and Senior Vice President of Research and Development, said: “Many patients are still struggling with ulcerative colitis (UC)-related symptoms, such as fatigue, bowel urgency, bloody diarrhea, and abdominal pain.
Upadacitinib has the potential to do It is an important new treatment option for UC patients who hope to solve these challenging and destructive symptoms
.
We look forward to working with regulatory agencies and hope to apply upadacitinib to the treatment of UC patients as soon as possible
Rinvoq clinical data
Ulcerative colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine, which can cause persistent mucosal inflammation, extending from the rectum to the closer colon to varying degrees
.
The hallmark signs and symptoms of UC include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus, urgency, and fecal incontinence
The active pharmaceutical ingredient of Rinvoq is upadacitinib, which is an oral selective and reversible JAK1 inhibitor discovered and developed by AbbVie.
It is being developed to treat several immune-mediated inflammatory diseases
.
JAK1 is a kinase that plays a key role in the pathophysiology of many inflammatory diseases
The industry is very optimistic about Rinvoq's business prospects
.
UBS analysts previously predicted that Rinvoq and AbbVie's other monoclonal antibody anti-inflammatory drug Skyrizi will have a peak sales of 11 billion U.
Humira is the world's first approved anti-tumor necrosis factor alpha (TNF-α) drug and the world's best-selling anti-inflammatory drug, with global sales in 2020 close to 20 billion U.
S.
dollars (19.
832 billion U.
S.
dollars)
.
In the European Union, a number of adalimumab biosimilars have been on the market
.
In the US market, Humira will be hit by biosimilars in 2023
.
(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
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
