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FDA approves Olumiant 2 mg for RA
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The FDA has approved a once-daily dose of baricitinib 2 mg for the treatment of adults with moderate-to-severe rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitors, according to a press release.
The decision follows an FDA Arthritis Advisory Committee meeting in April, in which the body voted 10-5 to recommend the 2 mg dose of baricitinib (Olumiant, Incyte & Eli Lilly) for RA, but rejected a 4-mg option for the same indication.
“We are delighted with today’s results — first and foremost, this is very important for patients who have failed on TNF inhibitors,” Terence Rooney, MD, senior medical director for Eli Lilly, told Healio Rheumatology. “The result is a valuable new treatment option for patients who, I think most physicians would agree, have the most substantial unmet need in RA care.”
The FDA based its decision on results from the RA-BEACON study, a randomized, double-blind, placebo-controlled trial of 527 patients who had an inadequate response or intolerance to one or more TNF inhibitors, or prior treatment with methotrexate or other disease-modifying antirheumatic drugs.
According to the FDA, baricitinib 2 mg is effective in reducing signs and symptoms, and in improving physical function, among patients with RA, compared to a placebo. It also exhibited higher ACR20 improvement figures than placebo at weeks 12 and 24, and demonstrated improvement in patients’ Health Assessment Questionnaire-Disability Index relative to placebo.
The FDA’s safety findings for baricitinib warned of risks for serious infection, including herpes zoster and tuberculosis, as well as malignancy, venous and arterial thrombosis and laboratory abnormalities. The approval comes with boxed warning for the risk of serious infections, malignancies and thrombosis, according to the press release.
In addition, as part of the approval, Eli Lilly and Incyte Corporation have agreed to conduct a randomized controlled clinical study to analyze the long-term safety of baricitinib in patients with RA.
According to Rooney, Eli Lilly plans to begin selling baricitinib in the United States by the end of the second quarter 2018. A Lilly press release stated the drug’s price will be “60% less than the leading TNF inhibitor.” The company will also offer a patient support program, Olumiant Together.
Eli Lilly and Incyte Corporation had initially submitted their application for baricitinib to the committee in January 2016, but was required to resubmit after the FDA issued a complete response letter due to the unfavorable benefit-risk regarding the potential risk for thrombosis.
In the most recent submission for the drug, issued in December 2017, the companies included new safety and efficacy data, and recommended a warning label for venous thromboembolism. Eli Lilly added that the risk for venous thromboembolism should be monitored in postapproval studies.
“RA patients continue to experience unique challenges accessing the treatments prescribed by their health care providers,” Christi Shaw, president of Eli Lilly, said in the release. “Therefore, we are determined to continue our work with stakeholders to demonstrate value across the health care system so providers have greater choice in prescribing treatments to fit individual patient needs.” – by Jason Laday