New anti-inflammatory drugs! AbbVie oral JAK1 inhibitor Rinvoq submits a new indication application in the U.S. and Europe to treat psoriasis arthritis (PsA)!

03/03/bio-
BiovalleyBIOON/ -- AbbVie recently announced that it has submitted to the U.SFood and Drug Administration (
FDA
) and the European Medicines Agency (EMA) a new application for oral anti-inflammatory drug Rinvoq (upadacitinib, 15 mg, once a day), which is a selectable and reversible JAK inhibitor for the treatment of active psoriasis patients (Ps)"Psoriasis arthritis is a complex heterogeneous disease that occurs across multiple areas, including joints and skin, leading to daily pain, fatigue and stiffness," said DrMichael Severino, Vice President and President ofAbbVieWe look forward to working with regulators and hope to bring Rinvoq to patients with this debilitating disease as soon as possible"
this new indication application, supported by data2 Phase III clinical studies SELECT-PsA-1 (NCT03104400) and SELECT-PsA-2 Study (NCT03104374)The two studies, which enrolled more than 2,000 active PsA patients, showed that in both studies, Rinvoq reached the primary endpoint of the ACR20 response compared to placeboIn addition, the 15 mg dose of Rinvoq and Adamu monoantigen showed no poor efficacy in the aCR20 response in the 12th week of treatmentPatients treated with Rinvoq also improved significantly in body function (HAQ-DI) and skin symptoms (PASI 75), and a greater proportion of patients achieved the lowest level of disease activity In PsA patients, Rinvoq's safety was consistent with the previously reported results of a clinical trial of Phase III rheumatoid arthritis , and no significant new safety risks were identified - SELECT-PsA-1:
was a multicenter, randomized, double-blind, parallel group, positive drug and placebo-controlled Phase III study, conducted in 1705 adult patients with at least one non-biological disease modified anti-rheumatic drug (DMARD) that were under-responded to, and evaluated two doses of Rinvoq (15mg and 30mg, once per day) in relation to the safety of placebo and adamus (a) In the study, patients were randomly assigned to receive Rinvoq 15mg, Rinvoq 30mg, Adamu monotonous (40mg, every other week, "EOW"), and placebo The main endpoint was the proportion of patients who reached ACR20 response at the 12th week compared to the placebo group with two doses of Rinvoq Secondary endpoints include changes in the relative baseline score of the 12th Week Health Assessment Questionnaire Disability Index (HAQ-DI), the proportion of patients who reached PASI75 (75% improvement in psoriasis criticality index) in week 16, and the proportion of patients who achieved the minimum disease activity (MDA) at Week 24 data showed that the study reached its main endpoint: in the 12th week, 71% of patients in the 15mg and 30mg groups met ACR20, respectively, and 36% in the placebo group (p 0.0001) When compared with Adamu monoantigen, both doses of Rinvoq achieved a non-disadvantage in terms of a20 response rate for treatment, with only 30 mg doses showing superiority In terms of a12-week ACR50 response rate, the 15mg group, the 30mg group and the placebo group were 38%, 52%, and 13% (nominal p 0.0001), respectively In terms of a75 response rate for week 12, 16%, 25%, and 2% (nominal p 0.0001) were in the 15mg group, 30mg group and placebo group measured on the basis of the HAQ-DI score, patients treated with Rinvoq also improved their physical function at week 12: the 15mg and 30mg Rinvoq treatment groups also had significant improvements in physical function: the 15mg and 30mg Rinvoq treatment groups had changes of 0.42 and -0.47, respectively, and the placebo group had a change of -0.14 (p 0.0001) At week 16, Rinvoq also showed an improvement in skin symptoms, with 63% and 62% of patients receiving doses of 15mg and 30mg Rinvoq reaching PASI75 and 21% in the placebo group (p 0.0001) The proportion of patients who reached MDA at the 24th week of treatment was 37% and 45% in the 15mg and 30mg Rinvoq treatment groups, and 12% in the placebo group (p 0.0001) After 24 weeks of treatment, 15mg and 30mg Rinvoq significantly inhibited radiology progression compared to placebo (p 0.01, with a change in the baseline relative to psA Sharp/van der Heijde scores) Inhibition of joint damage is important for patients with psoriasis arthritis because it affects body function and disability In the study, Rinvoq's security was consistent with previous lying and found no new security risks - SELECT-PsA 2:
is a multicenter, randomized, double-blind, parallel group, placebo-controlled study conducted in patients with active PsA who under-responded to at least one biodisease-modified anti-rheumatic drug (bDMARD) to assess the efficacy and safety of Rinvoq relative to placebo In the study, patients were randomly assigned to Receive Rinvoq 15mg, Rinvoq 30mg, placebo treatment, or Rinvoq 15mg or Rinvoq 30mg at week 24 The primary endpoint of the study was the percentage of patients who achieved ACR20 remission after 12 weeks of treatment, and the secondary endpoint included changes in the relative baseline of the Health Assessment Questionnaire Disability Index (HAQ-DI), the proportion of patients who reached ACR50 and ACR70 in Week 12, the proportion of patients who reached PASI 75 in week 16, and the proportion of patients who reached the lowest level of disease activity (MDA) at Week 24 The trial is under way and the long-term expansion trial is still blind to assess the long-term safety, tolerance and efficacy of two daily doses (15 mg and 30 mg) of Rinvoq in patients who have completed the placebo control period The results showed that two doses of Rinvoq (15 mg and 30 mg, once daily) reached the primary endpoint of ACR20 remission in week 12 compared to placebo In addition, two doses of Rinvoq showed significantly greater relief at all secondary endpoints than placebo specific data were: (1) At 12th week of treatment, 57% of patients with 15mg and 30mg doses of Rinvoq were given ACR20 remission, and the placebo group was 24% (p.0001) (2) At the 12th week of treatment, 32% of patients with 15mg and 30mg doses of Rinvoq met ACR50 relief and the placebo group 5 % (p 0.0001) were met, respectively (3) In the 12th week of treatment, 9% and 17% of patients in the 15mg and 30mg doses of Rinvoq met ACR70 remission, and the placebo group was 0.5% (p 0.0001) (4) In the 12th week of treatment, the body function (HAQ-DI evaluation) of patients treated with Rinvoq was improved considerably (5) Patients treated with Rinvoq showed improved skin symptoms, with 52% of patients in the 15mg and 30mg doses of Rinvoq in the 16th week of treatment, 57% of the patients with PASI75 relief and 16% in the placebo group (p 0.0001) (6) At the 24th week of treatment, 25% of patients with 15 mg and 30 mg doses of Rinvoq met MDA and 3% in the placebo group (p 0.0001) in the 15mg and 30mg doses (7) In this study, Rinvoq's security is consistent with previous studies and no new security risks were found Rinvoq's active pharmaceutical ingredient is upadacitinib, an oral selective and reversible JAK1 inhibitor discovered and developed by AbbVie that is being developed to treat several immunomediated inflammatory diseases JAK1 is a kinase that plays a key role in the pathophysiological process of a variety of inflammatory diseases August 2019, Rinvoq was the world's first to treat adult patients with moderate to severe active rheumatoid arthritis
(RA) who had inadequate or intolerant response to methotrexate (MTX) In December 2019, Rinvoq was approved by the European Union for the treatment of patients with moderate to severe RA who were under-responding to or intolerant of one or more disease-modified anti-rheumatic drugs (DMARD) In RA, Rinvoq approved a dose of 15 mg Currently, Phase III clinical study of Rinvoq for the treatment of psoriasis arthritis (PsA), RA, midashaft spinal arthritis (axSpA), Crohn's disease (CD), acursion dermatitis (AD), ulcerative colitis (UC), and cytomegaloarthritis (GCA) is currently under way the industry is very optimistic about Rinvoq's business prospects A previous report by Pharma, a pharmaceutical market research firm, predicted that Rinvoq's global sales would reach $2.57 billion by 2024, making it the world's fifth-best-selling anti-rheumatic drug (BioValleyBioon.com) original source: AbbVie Submits Regulatory app
lics to FDA and EMA for RINVOQ ™ (upadacitinib) for the Treatment of Adults with Active Psoticria arthritis