AbbVie’s Oral JAK1 Inhibitor Rinvoq Receives CHMP Positive Opinion for Two New Rheumatologic Indications in the EU

Dec 15, 2020 18:28 CST Updated 18:28

AbbVie

Innovative Drug Developer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

December 15, 2020 /BioValleyBIOON/ -- AbbVie recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of Rinvoq (upadacitinib) for two new rheumatologic indications: the treatment of adult patients with active psoriatic arthritis (PsA) and adult patients with active ankylosing spondylitis (AS). Currently, the applications for these two new indications of Rinvoq are also under review by the U.S.FDAreview.

Rinvoq is an oral, once-daily, selective, reversible JAK inhibitor. In the EU and the EU, Rinvoq was previously approved for the treatment of moderate to severe classRheumatoid Arthritis(RA) adult patients.

The CHMP’s opinion will now be submitted to the European Commission (EC) for review, with a final decision expected in early 2021. If approved, Rinvoq would become an oral, once-daily targeted therapy indicated for three rheumatologic indications in the European Union.

Psoriatic Arthritis (Image source: onhealth.com)

Psoriatic arthritis (PsA) is a complex, heterogeneous disease with manifestations spanning multiple domains, including the joints and skin, leading to daily pain, fatigue, and stiffness. Ankylosing spondylitis (AS) is a chronic, progressive, inflammatory musculoskeletal disorder that primarily causes pain and stiffness in the spine. The diverse symptoms of PsA and AS impose significant physical, psychological, and economic burdens on patients.

The application for the new indication of Rinvoq in the treatment of PsA is supported by data from two Phase III clinical studies, SELECT-PsA-1 (NCT03104400) and SELECT-PsA-2 (NCT03104374). These two studies enrolled more than 2,000 patients with active PsA. The results showed that in both studies, Rinvoq met the primary endpoint of ACR20 response compared with placebo. In addition, Rinvoq 15 mg demonstrated non-inferiority to adalimumab in terms of ACR20 response at Week 12. Patients treated with Rinvoq also showed greater improvements in physical function (HAQ-DI) and skin symptoms (PASI 75), and a higher proportion of patients achieved minimal disease activity.

Ankylosing Spondylitis (Image source: rehabmypatient.com)

The new indication application for Rinvoq in the treatment of AS is supported by data from the Phase 2/3 SELECT-AXIS 1 study (NCT03178487). The results showed that, compared with placebo, Rinvoq significantly improved symptoms and signs in adult patients with active AS. At Week 14 of treatment, the proportion of patients achieving ASAS40 (Assessment in SpondyloArthritis international Society 40% improvement) doubled (52% vs. 26%, p<0.001).

In the aforementioned three clinical studies, the safety profile of Rinvoq was consistent with that previously reported forRheumatoid Arthritis Clinical TrialsThe results were consistent, and no new significant safety risks were identified.

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 key role in the pathophysiology of various inflammatory diseases.

In August 2019, Rinvoq received its first global approval in the United States for the treatment of moderate to severe active rheumatoid arthritis in patients who have had an inadequate response or intolerance to methotrexate (MTX).Rheumatoid Arthritis(RA) adult patients. In December 2019, Rinvoq received EU approval for the treatment of moderate to severe RA in adult patients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). The approved dose of Rinvoq for RA is 15 mg.

Currently, AbbVie is developing Rinvoq for the treatment of multiple inflammatory diseases, including psoriatic arthritis (PsA), rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), Crohn’s disease (CD), atopic dermatitis (AD), ulcerative colitis (UC), and giant cell arteritis (GCA).

The industry holds a highly optimistic view of Rinvoq’s commercial prospects. Pharmaceutical market research firm EvaluatePharma previously released a report predicting that Rinvoq’s global sales would reach $2.57 billion in 2024, making it the fifth best-selling anti-rheumatic drug worldwide. (Bioon.com)

Original Source: CHMP Recommends theapprovals of RINVOQ (Upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis and Ankylosing Spondylitis