AbbVie has announced that the Food and Drug Administration (FDA) approved its rheumatoid arthritis (RA) drug Rinvoq (upadacitinib). Rinvoq is an oral Janus kinase (JAK) inhibitor designed for the treatment of moderate to severe RA in patients who did not respond or have an intolerance to methotrexate. The company reported that the JAK inhibitor will be available in the United States in late August.
Rinvoq will be sold for $59,000 a year in the U.S. Humira, also manufactured by AbbVie and indicated in the treatment of RA, costs an estimated $5,174 for a four-week supply, coming in at an annual cost of over $60,000.
Let's see if AbbVie can beat the number of patents it has received for Humira for its successor product Rinvoq which the FDA approved today for rheumatoid arthritis. Any predictions? https://t.co/T0lgwIqNZ7
— Tahir Amin (@realtahiramin) August 16, 2019
“Humira brought in global revenue of $4.87 billion in the second quarter, but sales have been hit by competition from cheaper rivals in Europe, and AbbVie in June announced a deal to buy Botox-maker Allergan Plc for $63 billion to reduce dependence on the drug,” according to a Reuters report. “The company has signed deals to prevent cheaper versions of Humira, which also treats psoriasis, from entering the United States, its biggest market, until 2023.”
Rinvoq will compete with fellow JAK inhibitors Olumiant and Xeljans, manufactured by Eli Lilly and Pfizer, respectively. According to Eli Lilly, the list price for Olumiant is $2,136.90 for a 30-day supply, totaling about $25,642.80 annually. Xeljans has an estimated cost of $4,686 for a supply of 60 5-mg tablets (a recommended dose is two 5-mg tablets daily), with the annual cost coming to roughly $56,232.
FDA approved $ABBV RINVOQ upadacitinib for RA with thrombosis blackbox – will see if this is class or not with future filgotinib label. Even though only 15mg is approved, some safety data from 30mg on label similar to baricitinib 2mg approved dose vs 4mg https://t.co/Nb6T44XYnm pic.twitter.com/ReeE8RxAp2
— JQ (@jq1234t) August 16, 2019
The FDA cautions that “Lymphoma and other malignancies have been observed in patients” taking Rinvoq, adding, “Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions.” In some cases, this could be fatal, noted the FDA.
FDA Approval Follows Five Trials
The FDA approval follows the SELECT program, which included five studies of RINVOQ that encompassed more than 4,400 patients.
“Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity—the primary treatment goals for rheumatoid arthritis,” said Roy M. Fleischmann, MD, SELECT-COMPARE’s primary investigator and clinical professor at the University of Texas Southwestern Medical Center at Dallas, in a press release. “With this FDA approval, RINVOQ has the potential to help additional people living with RA achieve remission who have not yet reached this goal.”
Abbvie $ABBV is pricing its new RA drug Rinvoq at $59k per year vs $60k plus for Humira. Gilead's $GILD Filgotinib needs FDA approval and a lower price in order to compete. You do the math! S&P 500 $XLV $XPH $IYH $IHI #SP500 $SPY $SPX pic.twitter.com/393nYoQqyD
— Ed Wijaranakula, Ph.D. (@wijaranakula) August 16, 2019
The SELECT-EARLY trial included patients who had never taken methotrexate and compared upadacitinib to methotrexate. Outcomes included 50% improvement in American College of Rheumatology criteria (ACR50). After 12 weeks, 52.1% of patients taking upadacitinib 15 mg achieved an ACR50 response, compared to 28.3% of methotrexate patients.
SELECT-MONOTHERAPY evaluated patients with inadequate response to methotrexate and compared patients who continued this treatment to upadacitinib patients. After 14 weeks, 68% of the upadacitinib 15 mg group achieved an ACR20 response compared to 41% of patients continuing methotrexate.
SELECT-COMPARE reported outcomes in patients with active disease despite methotrexate treatment. Patients treated with upadacitinib plus continued methotrexate, compared to methotrexate plus placebo, were more likely to achieve 12-week ACR20 (70.5% vs. 36.4%).
SELECT-NEXT included patients with inadequate respond to methotrexate or another conventional synthetic disease-modifying anti-rheumatic drug. After 12 weeks, ACR20 was attained by 64% of upadacitinib 15 mg patients compared to 36% of placebo patients.
SELECT-BEYOND yielded similar results: 12-week AR20 was achieved by 65% of upadacitinib 15 mg patients and 28% of placebo patients.