AbbVie's Rinvoq bags two new EU approvals

The European Commission (EC) has approved AbbVie’s Rinvoq (upadacitinib) for the treatment of active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).

The oral JAK inhibitor has been indicated for the treatment of active PsA in adult patients who have inadequately responded to or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

Rinvoq has also been indicated for the treatment of active AS in adult patients who have responded inadequately to conventional therapy.

These new approvals for Rinvoq were supported by data from three clinical trials – SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1.

In SELECT-PsA 1 and SELECT-PsA 2, Rinvoq met the primary endpoint of ACR20 response at week 12 versus placebo in active PsA patients.

AbbVie’s JAK inhibitor also achieved non-inferiority to Humira (adalimumab) for ACR20 at week 12, with Rinvoq-treated patients experiencing greater improvements in physical function and skin symptoms.

In addition, Rinvoq also met the primary endpoint of Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 14 versus placebo in the SELECT-AXIS 1 trial.

“Psoriatic arthritis and ankylosing spondylitis have a significant impact on many aspects of life for those living with these conditions,” said Tom Hudson, senior vice president, R&D, chief scientific officer, AbbVie.

“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,” he added.