AbbVie’s psoriatic arthritis and ankylosing spondylitis drug gets EU approval
pharmafile | January 26, 2021 | News story | Manufacturing and Production | AbbVie
The European Commission (EC) has approved AbbVie’s RINVOQTM (upadacitinib 15 mg), an oral, once-daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).
RINVOQ may be used as a monotherapy or in combination with methotrexate. The drug is also indicated for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy.
The EC approval is based on data from the three pivotal clinical trials, SELECT-PsA 1, SELECT-PsA 2, and SELECT-AXIS 1, demonstrating RINVOQ’s efficacy across multiple measures of disease activity.
In both Phase III clinical trials, SELECT-PsA 1 and SELECT-PsA 2, RINVOQ met the primary endpoint of ACR20 response at week 12, compared with placebo in adults with active PsA who had an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs) or biologic DMARDs, respectively. The treatment also achieved non-inferiority to adalimumab for ACR 20 at week 12.
Patients receiving RINVOQ experienced greater improvements in physical function (as measured by HAQ-DI at week 12) and skin symptoms (as measured by PASI-75 at week 16), and a greater proportion achieved minimal disease activity (MDA) compared to those receiving placebo at week 24.
The marketing authorisation means that RINVOQ is approved in all member states of the EU, as well as Iceland, Liechtenstein, and Norway. The drug is already approved for the treatment of adults with moderate to severe active rheumatoid arthritis.
Dr Tom Hudson, Senior Vice President of R&D and Chief Scientific Officer at AbbVie, said: “Psoriatic arthritis and ankylosing spondylitis have a significant impact on many aspects of life for those living with these conditions.
“We are proud to provide RINVOQ as a new treatment option to patients with PsA and a first-in-class treatment option to those living with AS. These approvals are important milestones in our commitment to develop a portfolio of solutions that advance standards of care for people living with rheumatic diseases.”
Darcy Jimenez
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