The FDA extended its review of Eli Lilly and Incyte's marketing application seeking approval of baricitinib for the treatment of moderate to severe rheumatoid arthritis by three months, the companies announced. The extension is to give the agency time to review additional data analyses recently submitted by Eli Lilly in response to a request from the regulator.
The filing for baricitinib was submitted in January 2016, following late-stage results announced the previous year that showed that the once-daily oral JAK inhibitor was superior to AbbVie's Humira (adalimumab) regarding ACR20 responses. J. Anthony Ware, senior vice president of product development at Eli Lilly, said "we will continue to work closely with the FDA throughout the review process and we believe that baricitinib has the potential to be an effective treatment choice, especially for those patients for whom current therapies are not adequately addressing their disease."
FirstWord reports in this therapy area - KOL Insight Rheumatoid Arthritis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
Baricitinib has also been filed for approval in the EU and Japan, with the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval of the drug in December 2016, which if authorised will be marketed as Olumiant. The therapy is also being studied in Phase II trials for atopic dermatitis and systemic lupus erythematosus, while a Phase III trial for patients with psoriatic arthritis is expected to start this year.
For related analysis, read ViewPoints: Eli Lilly ready to take a long-term view on its rheumatoid arthritis treatment baricitinib.
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