Another so-called JAK inhibitor, upadacitinib (Rinvoq), won FDA approval for treating rheumatoid arthritis, manufacturer AbbVie announced Friday.
The oral drug is indicated for patients with moderately to severely active disease who are intolerant or not responding adequately to methotrexate.
AbbVie said it expects to ship the product to pharmacies later this month.
Results from the company's SELECT clinical trial series showed upadacitinib was superior to placebo at rates similar to those seen with other approved rheumatoid arthritis drugs. Under a variety of conditions, patients receiving the drug achieved 20% reductions in symptoms by American College of Rheumatology criteria (ACR20) at rates of 60%-70%, compared with about 30%-40% in the placebo groups.
One trial tested the drug as first-line therapy in rheumatoid patients not previously treated with methotrexate, with ACR50 responses in 52% versus 28% of patients receiving methotrexate. But upadacitinib did not win approval for that population.
A head-to-head trial reported last year, meanwhile, showed an efficacy edge for upadacitinib over the industry leader, adalimumab (Humira), another AbbVie product.
Adverse effects were generally similar to those seen with other JAK inhibitors for rheumatoid arthritis; the most common were upper respiratory infections, fever, cough, and nausea. Upadacitinib's label will also note risk for more serious infections, most often seen in patients receiving immunosuppressants including methotrexate, as well as other rare complications.
Other JAK inhibitors previously approved for rheumatoid arthritis include tofacitinib (Xeljanz) and baricitinib (Olumiant). AbbVie will reportedly price upadacitinib at $59,000 a year at wholesale, nearly the same as for Humira.