AbbVie's Oral JAK1 Inhibitor Rinvoq Receives EU Approval for Moderate to Severe Rheumatoid Arthritis, Projected Annual Sales of $2.6 Billion
Dec 20, 2019 08:29
CST Updated
08:29
AbbVie
Innovative Drug Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
December 20, 2019 News /BioValleyBIOON/ -- U.S. biopharmaceutical giant AbbVie recently announced that the European Commission (EC) has approved the JAK1 inhibitor Rinvoq (upadacitinib) for the treatment of moderate to severe rheumatoid arthritis in patients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).Rheumatoid Arthritis(RA) Treatment of adult patients. Rinvoq is a once-daily, selective, reversible JAK inhibitor that can be used as monotherapy or in combination with methotrexate (MTX).
In the United States, Rinvoq was approved in mid-August this yearFDAApproved for the treatment of moderate to severe active rheumatoid arthritis in patients who have had an inadequate response or intolerance to methotrexate (MTX-IR)Rheumatoid Arthritis(RA) treatment for adult patients. Currently, Rinvoq is marketed in the United States; this medication is administered orally at a dose of 15 mg once daily and is not indicated for patients who have not previously been treated with MTX. Rinvoq also marks AbbVie’s U.S. approval this yearFDAThe second approved targeted immunomodulator (TIM) therapy. Notably, AbbVie utilized a Priority Review Voucher (PRV) to accelerate the review of Rinvoq, shortening the review cycle from the standard 10 months to 6 months.
Michael Severino, Vice Chairman and President of AbbVie, stated, “We are proud to provide for moderate to severeRheumatoid Arthritis“This once-daily tablet provides patients with a new treatment option. As a company dedicated to discovering and delivering transformative therapies for patients with rheumatic diseases for nearly 20 years, Rinvoq expands our portfolio of treatment options available to patients with rheumatic diseases in Europe.”
Rinvoq was approved in the United States and the European Union, based on data from the global SELECT Phase III rheumatoid arthritis (RA) program. This program is one of the largest registration-enabling 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 been previously announced, with the primary endpoint results as follows:
—SELECT-EARLY Study: Conducted in MTX-naïve patients, 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: Conducted in MTX-IR patients, at Week 14 of treatment, 68% of patients in the Rinvoq 15 mg group achieved ACR20 response, compared to 41% in those who continued MTX therapy.
—SELECT-COMPARE Study: Conducted 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: Conducted in patients with an inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARD-IR). At Week 12, 64% of patients in the Rinvoq 15 mg + csDMARD treatment group achieved ACR20 response, compared with 36% in the placebo + csDMARD group.
——SELECT-BEYOND Study: Conducted 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 to 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 for the treatment of psoriatic arthritis (PsA), Crohn’s disease (CD), atopic dermatitis (AD), ulcerative colitis (UC), and giant cell arteritis are underway. Furthermore, upadacitinib is also being evaluated for the treatment of ankylosing spondylitis.
The industry holds a highly optimistic view of Rinvoq’s commercial prospects. EvaluatePharma, a pharmaceutical market research firm, previously released a report predicting that Rinvoq’s global sales would reach $2.57 billion in 2024, making it the fifth best-selling antirheumatic drug worldwide. (Bioon.com)