The FDA has nixed Eli Lilly's and Inctye's application for baricitinib in its current form asking for additional safety and clinical data.
The Food and Drug Administration has nixed Eli Lilly's and Inctye's application for baricitinib in its current form and is asking for additional safety and clinical data.
Baricitinib, a once daily oral JAK inhibitor for people with moderate to severe rheumatoid arthritis, performed well in clinical trials in recent years, but the FDA has asked for additional clinical data to determine appropriate doses and safety data to address safety concerns across treatment arms.
“We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.," the two companies stated in a written statement.
Eli Lilly and Inctye Corp. submitted a new drug application to the FDA in January 2016. "The timing of a resubmission will be based on further discussions with the FDA," the companies stated.
On Feb. 13, the European Commission granted marketing authorization to Eli Lilly and Inctye for baricitinib (Olumiant) for adults with moderate to severe active rheumatoid arthritis, but specifically for patients who do not respond to DMARD treatment or who cannot tolerate DMARDs.
JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, which suggests they may be useful targets of inflammatory conditions.
There were four phase three clinical trials of baricitinib in patients with moderate- to-severe rheumatoid arthritis. One of the studies was designed to compare baricitinib outcomes to methotrexate (RA-BEGIN) and a second, compared outcomes to adalimumab (RA-BEAM). A third phase three study was conducted in China.
A study published in a January issue of the Annals of the Rheumatic Diseases compared baricitinib to conventional DMARDs. The phase three, double-blind, 24-week study of 684 patients who previously had an inadequate response to or intolerance a conventional synthetic disease-modifying anti-rheumatic drug (DMARD), showed that patients receiving 2 mg or 4 mg of baricitinib once daily achieved ACR20 response at week 12 with baricitinib 4 mg.
A systematic review published last month in Zeitschrift fur Rheumatologie found that patients receiving baricitinib 4 mg in combination with a DMARD, had significantly higher rates of achieving ACR20 response. The review is based on a meta-analysis of seven randomized controlled trials involving 3,461 patients.
Baricitinib is currently in clinical studies for inflammatory and autoimmune diseases, including a phase two study for systemic lupus erythematosus and atopic dermatitis. A phase three trials for psoriatic arthritis is expected to start later this year.
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U.S. FDA Issues Complete Response Letter for Baricitinib, Eli Lilly and Inctye Corp., statement, April 14, 2017.
Peter C. Taylor, Edward C. Keystone, DÃ©sirÃ©e van der Heijde, et al. “Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis,” New England Journal of Medicine. Published February 16, 2017. DOI: 10.1056/NEJMoa1608345.