New anti-inflammatory drugs! AbbVie oral JAK1 inhibitor Rinvoq is recommended by CHMP in the European Union for the treatment of 2 new rheumatoids!

December 15, 2020 // -- AbbVie recently announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued an active review recommending approval of Rinvoq (upadacitinib) for two new rheumatoid adaptations: the treatment of active psoriasis arthritis (PsA) in adult patients and active spina bifida (AS) adult patients.
, Rinvoq's two new adaptation applications are also under review by the FDA.
Rinvoq is an oral, daily, selective, reversible JAK inhibitor.
in the European Union and the European Union, Rinvoq has previously been approved for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA).
, CHMP's comments will now be submitted to the European Commission, which is expected to make a final review decision in early 2021.
approved, Rinvoq will become an oral, daily targeted treatment for three rheumatoid adaptations in the European Union.
Psoriasis Arthritis (Photo: onhealth.com) Psoriasis Arthritis (PsA) is a complex heterogeneity disorder that manifests it itly in many 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.
application for Rinvoq's treatment of PSA is supported by data from 2 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.
application for Rinvoq's treatment of AS for severe orthopaedic spina belitis (Photo: rehabmypatient.com) is supported by 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 do not respond well or are insatiable to one or more disease-modified rheumatoid 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.
a report by Evaluate Pharma, a pharmaceutical market research organization, predicted that Rinvoq's global sales would reach $2.57 billion by 2024, making it the world's fifth-best-selling anti-rheumatoid drug.
() Original source: CHMP Recommends the approvals of RINVOQ (Upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis and Ankylosing Spondylitis