Citing safety concerns, FDA delayed approval of a new blockbuster drug to treat rheumatoid arthritis.
Citing safety concerns, FDA delayed approval of a new blockbuster drug to treat rheumatoid arthritis (RA).
FDA said that more clinical data is needed because of safety concerns across treatment arms of the new investigational drug baricitinib (Eli Lilly and Company, Incyte Corporation). Additional clinical data is needed to determine the most appropriate doses, the two manufacturers said in a statement.
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While Lilly and Incyte agree with FDA’s conclusions, "We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA," said Christi Shaw, president of Lilly Bio-Medicines, in the statement. "We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the US"
Lilly and Incyte submitted the NDA for baricitinib to the FDA in January, 2016. This January, FDA granted a 3-month extension to review additional data. In addition, Lilly and Incyte submitted the drug for regulatory review seeking marketing approval in the European Union (EU) and Japan in 2016, and baricitinib was approved in the EU in February 2017.
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Baricitinib is a once-daily oral JAK inhibitor, currently being studied for inflammatory and autoimmune diseases. There are 4 known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions, including RA.
The drug is being studied in phase 2 trials for atopic dermatitis and systemic lupus erythematosus, and a phase 3 trial for patients with psoriatic arthritis, which will start sometime this year.
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