AbbVie’s Oral JAK1 Inhibitor Rinvoq Receives Third Global Regulatory Approval for Rheumatoid Arthritis, Projected Annual Sales of $2.6 Billion

January 09, 2020 /BioValleyBIOON/ -- U.S. biopharmaceutical giant AbbVie recently announced that Health Canada has approved the JAK1 inhibitor Rinvoq (upadacitinib) for the treatment of moderate to severe rheumatoid arthritis in patients who have had an inadequate response to or intolerance of methotrexate (MTX).Rheumatoid Arthritis(RA) Treatment of adult patients. This medication is a selective, reversible JAK inhibitor administered orally once daily, and can be used as monotherapy or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs).

In August 2019, Rinvoq received its first global approval in the United States. The drug is currently marketed in the U.S. as a once-daily oral tablet (15 mg) and is not indicated for patients who have not previously been treated with methotrexate (MTX). Notably, AbbVie utilized a Priority Review Voucher (PRV) to expedite the U.S. approval of Rinvoq.FDAreview. In December 2019, Rinvoq received EU approval for the treatment of adult patients with moderate to severe RA who have had an inadequate response or intolerance to one or more DMARDs.

Dr. Edward Keystone, Professor of Medicine at the University of Toronto, stated, “Although tremendous progress has been made in the treatment of rheumatoid arthritis over the past 20 years, too many patients still fail to achieve remission and continue to suffer from pain, fatigue, and morning joint stiffness. Rinvoq boasts one of the largest Phase IIIClinical TrialProject support, this drug has the potential to significantly improve the symptoms and signs of the disease.”

Rinvoq has been approved in the United States, the European Union, and Canada, based on data from the global SELECT Phase III rheumatoid arthritis (RA) program. This program is one of the largest registrational Phase III programs conducted in the field of RA, comprising five Phase III studies with more than 4,400 enrolled RA patients. These studies evaluated the efficacy, safety, and tolerability of Rinvoq across various RA patient populations, including those who had failed or were intolerant to biologic disease-modifying antirheumatic drugs (bDMARDs), as well as those who were methotrexate (MTX)-naïve or had an inadequate response to MTX. In all studies, Rinvoq met both primary and secondary endpoints: it improved signs and symptoms of RA, inhibited radiographic progression, and enhanced physical function, both as monotherapy and in combination with conventional synthetic DMARDs (csDMARDs). Regarding safety, the most common serious adverse events were infections. The top-line data from these studies have previously been announced, with the primary endpoint data as follows:

——The SELECT-EARLY Study:Conducted in patients who had not previously received MTX, at Week 12 of treatment, 52% of patients in the Rinvoq 15 mg group achieved ACR50 response, compared with 28% in the MTX group.

——SELECT-MONOTHERAPY Study:In patients with MTX-IR, at Week 14 of treatment, 68% of patients in the Rinvoq 15 mg group achieved ACR20 response, compared with 41% of patients who continued to receive MTX therapy.

——The SELECT-COMPARE Study:In MTX-IR patients, at Week 12 of treatment, 71% of patients in the Rinvoq 15 mg + MTX group achieved ACR20 response, compared with 36% in the placebo + MTX group.

——SELECT-NEXT Study:In patients with an inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR), 64% of patients in the Rinvoq 15 mg + csDMARD treatment group achieved ACR20 response at Week 12, compared with 36% in the placebo + csDMARD group.

——SELECT-BEYOND Study:In patients with an inadequate response or intolerance to biologics (biologic-IR), at Week 12 of treatment, 65% of patients in the Rinvoq 15 mg + csDMARD group achieved ACR20 response, compared with 28% in the placebo + csDMARD group.

The active pharmaceutical ingredient of Rinvoq is upadacitinib, an oral selective JAK1 inhibitor discovered and developed by AbbVie, which is being developed for the treatment of moderate-to-severe RA and other immune-mediated diseases.

JAK1 is a kinase that plays a pivotal role in the pathophysiology of various inflammatory diseases. Currently, Phase III clinical trials of upadacitinib are underway for the treatment of psoriatic arthritis (PsA), Crohn’s disease (CD), atopic dermatitis (AD), ulcerative colitis (UC), and giant cell arteritis. In addition, upadacitinib is also being evaluated for the treatment of ankylosing spondylitis.

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

Original Source:AbbVie Receives Health Canada Approval of RINVOQ® (upadacitinib), an Oral Medication for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis Français