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Home CHMP Recommends Approval of AbbVie’s Oral JAK1 Inhibitor Rinvoq for Moderate-to-Severe Atopic Dermatitis in Adults and Adolescents in the EU

CHMP Recommends Approval of AbbVie’s Oral JAK1 Inhibitor Rinvoq for Moderate-to-Severe Atopic Dermatitis in Adults and Adolescents in the EU

Jun 28, 2021 00:25 CST Updated 00:25
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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.


Atopic Dermatitis (Image source: icresearch.net)

June 26, 2021 /BioonBIOON/ -- AbbVie recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of a new indication for Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis (AD) in adult patients who are candidates for systemic therapy (15 mg or 30 mg, once daily) and adolescent patients aged 12 years and older (15 mg, once daily).

Currently, the CHMP opinion will be submitted to the European Commission (EC) for review, which is expected to issue a final decision within the next two months.If approved, this will be the fourth indication for Rinvoq in the European Union, and Rinvoq will also become the first JAK inhibitor in the EU for the treatment of adult and adolescent (≥12 years) patients with moderate-to-severe AD.

Rinvoq is an oral, once-daily, selective, reversible JAK inhibitor. In the European Union, Rinvoq has previously been approved for three indications.: (1) for the treatment of moderate to severe rheumatoid in patients with an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs)Rheumatic arthritis(RA) in adult patients; (2) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more DMARDs; (2) for the treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy. For these indications, the approved dose of Rinvoq is 15 mg.

The positive CHMP opinion was supported by data from the global Phase 3 program. The program included three pivotal global studies (Measure Up 1, Measure Up 2, and AD Up), which enrolled over 2,500 patients with moderate-to-severe atopic dermatitis (AD). Across all three studies, both doses of Rinvoq met all primary and secondary endpoints: compared with the placebo group, patients treated with Rinvoq demonstrated rapid and significant improvements in skin clearance and pruritus at Week 16 and other time points (p<0.001). In the studies, the most common among patients treated with RinvoqAdverse Reactionsare acne, nasopharyngitis, and upper respiratory tract infections.

In the United States, Rinvoq is approved only for the treatment of moderate to severe active rheumatoidRheumatic arthritis(RA) Adult Patients, the approved dose for this indication is 15 mg. Currently, the supplemental application for Rinvoq in the treatment of PsA, AS, and AD is under review by the U.S.FDAof the review.

Recently, AbbVie also provided a U.S. regulatory update on Rinvoq for the treatment of PsA and AS.FDAThe company has been notified that a decision on the supplemental New Drug Application (sNDA) for Rinvoq for the treatment of PsA and AS will not be reached by the PDUFA target date. Currently, the agency isPfizerof a post-marketing study, ORAL Surveillance, which is evaluating the safety of the oral JAK inhibitor Xeljanz (tofacitinib) in the treatment of RA. Currently,FDANo formal regulatory action has been taken on the sNDA for Rinvoq for the treatment of PsA and AS. Additionally, the sNDA for Rinvoq for the treatment of AD was delayed by three months in April this year, to the third quarter of 2021.

Atopic dermatitis (AD) is a common, chronic, relapsing, inflammatory skin disease characterized by a recurrent itch-scratch cycle, leading to skin cracking, scaling, and oozing. It is estimated that up to 25% of children and 10% of adults will be affected by AD at some point in their lives. Between 20% and 46% of adult patients with AD experience moderate-to-severe disease. The symptoms of this disease impose a substantial physical, psychological, and economic burden on patients.

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 critical role in the pathophysiology of various inflammatory diseases.

Currently, Rinvoq treats ulcerative colitis (UC), rheumatoidRheumatic ArthritisPhase III clinical trials for (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), Crohn's disease (CD), atopic dermatitis (AD), and giant cell arteritis (GCA) are ongoing.

The industry is highly optimistic about the commercial prospects of Rinvoq. UBS Group analysts previously predicted that the peak sales of Rinvoq and Skyrizi, another monoclonal antibody anti-inflammatory drug from AbbVie, would reach $11 billion. These two new products will be able to offset the challenges faced by AbbVie’s flagship product, Humira (adalimumab), as it encountersBiosimilarSales losses resulting from the impact.

Humira is the world's first approved anti-TumorTumor necrosis factor-α (TNF-α) drug, and also the world's best-selling anti-inflammatory medication, with global sales reaching nearly $20 billion ($19.832 billion) in 2020. In the European Union, multiple adalimumab biosimilars have already been launched and are commercially available. Meanwhile, in the U.S. market, Humira will in 2023 be subject toBiosimilarImpact. (Bioon.com)