Public Citizen Urges FDA to Reject Approval of Rheumatoid Arthritis Medication

April 23, 2018

Public Citizen Urges FDA to Reject Approval of Rheumatoid Arthritis Medication

Baricitinib Has No Unique Benefits, But Causes Unique Life-Threatening Harm

The U.S. Food and Drug Administration (FDA) should not approve baricitinib, a medication that would be used to treat adults with rheumatoid arthritis, because it causes unique life-threatening harms and lacks any unique benefit over the very similar FDA-approved medication tofacitinib, Dr. Michael Carome, director of Public Citizen’s Health Research Group, said to the FDA’s Arthritis Advisory Committee today.

The FDA rejected the medication in April 2017 after concluding that it has an unfavorable risk-benefit profile. Of particular concern, data from randomized clinical trials shows that baricitinib, which was developed by Eli Lilly and Company, can cause potentially fatal blood clots, a risk not seen with other similar rheumatoid arthritis medications. The company resubmitted an application for approval of the product, but did not provide any new data that substantially alters the agency’s original conclusion.

According to Carome, approval of baricitinib would show blatant disregard for the public health principles underlying the FDA’s regulatory authority.

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