AbbVie Seeks FDA, EMA Approvals of Rinvoq for Active AS

AbbVie has submitted an application to the U.S. Food and Drug Administration (FDA) requesting the approval of Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis (AS).

A separate application was submitted to the European Medicines Agency (EMA) by AbbVie earlier this year, requesting the approval of Rinvoq for the treatment of adults with active AS who have responded inadequately to conventional therapy.

“With limited treatment options, innovation is crucial to help more patients living with active ankylosing spondylitis reach their treatment goals,” Michael Severino, MD, AbbVie’s vice chairman and president, said in a press release.

“RINVOQ has the potential to improve care by helping to provide disease control, addressing pain and improving function,” Severino said. “We look forward to working with regulatory authorities and hope to bring this important treatment option to patients.”

A selective Janus kinase (JAK) inhibitor, Rinvoq works as an immunosuppressant by targeting the JAK enzyme in cells, which are essential for regulation.

In both the U.S.and the European Union, Rinvoq has already been approved to treat moderate-to-severe rheumatoid arthritis. It is a therapy in the U.S. for patients who are not responding or are intolerant to methotrexate. In the EU, it is approved for individuals who are not responding or are intolerant to disease-modifying anti-rheumatic drugs. The approved dose for these indications is 15 mg.

The medication also is being investigated in other inflammation-driven diseases, including Crohn’s disease, ulcerative colitis, atopic dermatitis, and psoriatic arthritis.

Both of AbbVie’s regulatory applications for Rinvoq in active AS are supported by data from the Phase 2/3 clinical trial SELECT-AXIS 1 (NCT03178487). This study enrolled 187 people with active AS who either responded poorly to or were unable to take non-steroidal anti-inflammatory drugs (NSAIDs) — which include aspirin and ibuprofen, sold as Advil or Motrin, among others.

The participants received either Rinvoq or a placebo for 14 weeks in the trial’s first part. The primary measurement of efficacy was the proportion of patients who experienced at least a 40% improvement in their condition, as evaluated with the Assessment of SpondyloArthritis International Society (ASAS). Notably, the ASAS criteria analyze four areas: pain, function, inflammation, and a patient global assessment.

The results showed that significantly more participants on Rinvoq, relative to a placebo, met this goal (52% vs. 26%). Other benefits with Rinvoq included a greater proportions of patients in partial remission and with a reduction in disease activity, as analyzed by ASAS and the Bath AS Disease Activity Index, or BASDAI.

The safety profile of Rinvoq in this clinical trial was consistent with the results of trials for other diseases. No new safety concerns were identified. The most commonly reported side effect of Rinvoq was elevated levels of creatine phosphokinase, a marker of tissue damage.