FDA Delays Approval on Baricitinib for RA, Wants More Data

Megan Brooks

April 17, 2017

The US Food and Drug Administration (FDA) said it cannot approve the new drug application for baricitinib in its current form. Baricitinib is a once-daily oral Janus kinase (JAK) inhibitor for the treatment of moderate to severe rheumatoid arthritis (RA).

In a complete response letter to the drug's developers, Eli Lilly and Company and Incyte Corporation, the FDA said that additional clinical data are needed to determine the most appropriate doses and to further characterize safety concerns across treatment arms.

In a news release, the companies say they disagree with the FDA's conclusions. They noted that the timing of a resubmission will be based on further discussions with the agency.

"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. We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the US," Christi Shaw, president of Lilly Bio-Medicines, said in the release.

Baricitinib is a small-molecule once-dialy oral JAK inhibitor that preferentially inhibits JAK1 and JAK2. The JAK family of kinases has been implicated in the autoimmune inflammatory response.

Baricitinib was tested in four "successful" pivotal phase 3 clinical trials in patients with moderate to severe RA to support regulatory submission in most countries, the companies say.

Two of the studies included prespecified comparisons to approved disease-modifying antirheumatic drugs (DMARDs): one to methotrexate (RA-BEGIN), and one to adalimumab (RA-BEAM).

The clinical trial program involves a wide range of patients, including those who are methotrexate-naive, those who experienced an inadequate response to methotrexate, those who experienced an inadequate response to conventional synthetic DMARDs, and those tho experienced an inadequate response to biologic DMARDs, including tumor necrosis alpha inhibitors, the companies note.

Baricitinib was submitted for regulatory review in which approval was sought for the treatment of RA in the United States, the European Union, and Japan in 2016. It was approved in the EU in February 2017.

It is being studied in phase 2 trials for atopic dermatitis and systemic lupus erythematosus. A phase 3 trial for patients with psoriatic arthritis is expected to be initiated in 2017.

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