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26, 2021 // -- AbbVie recently announced that the European Commission (EC) has approved Rinvoq (upadacitinib, 15mg) for two new rheumatoid adaptations: (1) for the treatment of a pair of Adult patients with active psoriasis arthritis (PsA) who have inadequate or insufferable response to anti-rheumatoid drugs (DMARD) for one or more disease modifications, and (2) for the treatment of adult patients with active or straight spina bifiditis (AS) who do not respond well to conventional therapies.
in the European Union, Rinvoq has previously been approved for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA).
with this latest approval, Rinvoq became the first EU-approved oral, daily, selective, reversible JAK inhibitor to be used to treat three rheumatoid adaptations (RA, PsA, AS).
this approval is based on data from three key clinical trials, SELECT-PsA 1, SELECT-PsA 2, and SELECT-AXIS, which confirm the efficacy of Rinvoq in a variety of disease activity evaluation indicators.
, senior vice president of research and development at AbbVie and Chief Scientific Officer, said,
S. M.D., Psoriasis Arthritis and Strong Spina blanditis have a significant impact on many aspects of a patient's life.
we are proud to offer Rinvoq as a new treatment option for PSA patients and the first of its kind for AS patients.
approvals are an important milestone in our commitment to developing solutions that will raise standards of care for people with rheumatoid patients.
"Psoriasis Arthritis (Photo: onhealth.com) Psoriasis Arthritis (PsA) is a complex heterogeneity disorder that manifests it itly across multiple fields, including joints and skin, leading to daily pain, fatigue and stiffness.
as is a chronic, aggressive, inflammatory musculoskeletal disease that causes pain and stiffness in the spine.
symptoms of PSA and AS can place a significant physical, psychological and financial burden on patients.
Rinvoq to treat PSA's new adaptations, based on data support from two Phase III clinical studies, SELECT-PsA-1 (NCT03104400) and SELECT-PsA-2 (NCT03104374).
study, which included more than 2,000 active PSA patients, showed that in both studies, Rinvoq reached the primary endpoint of the ACR20 response compared to a placebo.
, 15 mg doses of Rinvoq and Adamo monoantigen showed non-poor effectiveness in treating the ACR20 response at week 12.
patients treated with Rinvoq also experienced greater improvements in physical function (HAQ-DI) and skin symptoms (PASI 75), and a larger proportion of patients achieved the lowest levels of disease activity.
strong orthopaedic spinalitis (Photo: rehabmypatient.com) Rinvoq treats AS's new adaptation, based on data from the 2/3 SELECT-AXIS 1 Study (NCT03178487).
results showed that Rinvoq significantly improved symptoms and signs in adult patients with active AS compared to placebo, and doubled the proportion of patients who reached ASAS40 (40 percent improvement in the International Society for Spinal Arthritis Assessment) in week 14 (52 percent vs. 26 percent, p<0.001).
of the three clinical studies, Rinvoq's safety was consistent with previously reported clinical trial results for rheumatoid arthritis, and no significant new safety risks were found.
Rinvoq's active drug ingredient is upadacitinib, an oral selective and reversible JAK1 inhibitor discovered and developed by AbbVie and is being developed to treat several immunomedulated inflammatory diseases.
JAK1 is a kinase that plays a key role in the pathophysiology of a variety of inflammatory diseases.
August 2019, Rinvoq received the world's first treatment in the United States for adult patients with moderate to severe active rheumatoid arthritis (RA) who have inadequate or insatiable response to methotrexate (MTX).
December 2019, Rinvoq was approved by the European Union to treat adult patients with moderate to severe RA who have inadequate or insatiable response to one or more disease-modified rheummatoid drugs (DMARD).
in RA, the approved dose for Rinvoq is 15 mg.
Currently, AbbVie is developing Rinvoq to treat a variety of inflammatory diseases, including psoriasis arthritis (PsA), RA, mid-axis spinal arthritis (axSpA), Crohn's disease (CD), adiopathic dermatitis (AD), ulcerative colitis (UC), and cytoarthritis (GCA).
industry is very bullish on Rinvoq's business prospects.
report by Evaluate Pharma, a pharmaceutical market research organization, predicts that Rinvoq will have global sales of $2.57 billion by 2024, making it the world's fifth-best-selling anti-rheumate drug.
() Origin: European Commission approves AbbVie's RINVOQ™ for The Treatment of Psoriatic Arthritis and Ankylosing Spondylitis