US approves AbbVie's JAK inhibitor Rinvoq for moderate-to-severe rheumatoid arthritis

AbbVie announced Friday that the FDA has cleared Rinvoq (upadacitinib) to treat adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. The company also plans to launch the once-daily oral JAK inhibitor in the US in late August at a price of $59,000 a year. 

By contrast, a four-week supply of AbbVie's Humira (adalimumab) carries a list price of about $5174, amounting to over $60,000 annually. Humira sales fell a little over 6% in the second quarter to $4.9 billion, hit by biosimilar competition. In June, the drugmaker agreed to acquire Allergan for $63 billion in a bid to reduce its reliance on the drug.

Meanwhile, FDA approval of Rinvoq was supported by data from the Phase III SELECT programme, which assessed the treatment in about 4400 patients with RA across five studies. Results from the SELECT-COMPARE trial, which involved 1629 patients with RA who were on a stable background of methotrexate, but who exhibited an inadequate response, showed that Rinvoq was associated with significantly higher ACR20 and clinical remission rates than placebo. 

"Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity," remarked Roy Fleischmann, primary investigator for the SELECT-COMPARE study, adding that "Rinvoq has the potential to help additional people living with RA achieve remission who have not yet reached this goal." Rinvoq remains under review by regulatory authorities in Europe, Canada and Japan. 

In 2012, the FDA approved Pfizer's JAK inhibitor Xeljanz (tofacitinib) for use in patients with moderately-to-severely active RA who have an inadequate response or intolerance to methotrexate. A lower dose of Eli Lilly and Incyte's JAK inhibitor Olumiant (baricitinib) was cleared in the US last year for adults with moderately-to-severely active RA who have had an inadequate response to TNF inhibitors. An FDA advisory panel had raised safety concerns regarding a higher dose of the drug. Meanwhile, Gilead Sciences has said it plans to seek US approval for its JAK inhibitor filgotinib before the end of this year to treat patients with RA.   

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