AbbVie Announces $59,000 Annual Price for JAK Inhibitor Rinvoq, Set to Launch in U.S. by End of August

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Last Friday, AbbVie’s highly anticipated JAK1 inhibitor, Rinvoq (upadacitinib), a novel anti-inflammatory agent, received approval from the U.S. FDA for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or intolerance to methotrexate (MTX-IR). Administered orally at a recommended dose of 15 mg once daily, Rinvoq can be used as monotherapy or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs). This medication is not indicated for patients who have not previously been treated with MTX.

AbbVie recently announced the pricing for Rinvoq, with an annual treatment cost of $59,000, comparable to that of Humira, which requires regular injections and costs $60,000 per year. Clinical data indicate that Rinvoq is more effective than Humira in treating moderate-to-severe rheumatoid arthritis (RA).

The FDA’s approval of Rinvoq was based on data from the Phase III clinical program SELECT, one of the largest registrational Phase III programs conducted in the rheumatoid arthritis (RA) field, involving approximately 4,400 patients treated across five studies. The program evaluated the efficacy, safety, and tolerability of Rinvoq in various types of RA patients, including those who had failed or were intolerant to biologic disease-modifying antirheumatic drugs (bDMARDs), including TNF inhibitors such as Humira, as well as patients who were methotrexate (MTX)-naïve or had an inadequate response to MTX. In all five studies, Rinvoq met both primary and secondary endpoints.

Rinvoq is not the first JAK inhibitor to challenge TNF inhibitors, but it is the first JAK inhibitor with data clearly demonstrating superiority across multiple endpoints. AbbVie expects Rinvoq to enter the U.S. market by late August, where it will compete with Pfizer’s Xeljanz and Eli Lilly’s Olumiant, both of which have been approved by the FDA for the treatment of rheumatoid arthritis (RA).

Notably, last month, the FDA added a boxed warning to the drug label for Xeljanz, highlighting an increased risk of potentially fatal blood clots. Furthermore, due to safety concerns, the FDA approved only the low 2 mg dose of Olumiant, rejecting the 4 mg dose; its drug label also carries warnings regarding serious infections, cancer, and thrombosis. Rinvoq was not exempt either, as its drug label likewise includes warnings about the risk of blood clots. However, AbbVie maintains that the side effects of Rinvoq are identifiable and manageable, and will not pose an obstacle to sales.

Rinvoq is the second immunomodulatory therapy approved by the U.S. FDA for AbbVie this year, following Skyrizi. These two products are considered key to supporting the company’s performance in the “post-Humira era,” helping to offset the anticipated decline in Humira sales after adalimumab biosimilars enter the U.S. market (currently expected in 2023). Skyrizi, a monoclonal antibody that selectively inhibits IL-23, was approved in April of this year for the treatment of moderate-to-severe plaque psoriasis.

According to a recent analysis by Clarivate, Rinvoq’s sales in 2023 are projected to exceed $2 billion, surpassing Olumiant but trailing Xeljanz, whose sales for the same period are estimated at $3.3 billion. Clarivate also forecasts that Skyrizi’s sales will reach $1.7 billion during the same timeframe.

Competition within the JAK inhibitor class is expected to intensify in the future. Gilead and Galapagos are awaiting a regulatory decision from the European Medicines Agency on their JAK inhibitor, filgotinib, and both companies plan to submit a U.S. marketing application by the end of the year. Meanwhile, Pfizer is developing abrocitinib, an upgraded version of Xeljanz. As a next-generation JAK inhibitor, abrocitinib has been granted Breakthrough Therapy Designation by the FDA and is considered capable of avoiding the thrombotic risks commonly associated with JAK inhibitors.

Reference Sources:

1、AbbVie prices Rinvoq close to Humira after arthritis approval

2、AbbVie Receives FDA Approval of RINVOQ^™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to SevereRheumatoid Arthritis

Original Title:$59,000/Year! AbbVie Officially Announces Pricing for JAK Inhibitor Rinvoq, Launching in the U.S. in Late August!