Eli Lilly Preps Rejected Rheumatoid Arthritis Drug for Resubmission

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In July, Lilly (NYSE: LLY) said discussions with the regulator included the possibility of requiring an additional study.Lilly said the FDA had expressed concern about blood clots observed during clinical trials and it asked the company to provide more information about dosing and safety.Rheumatoid arthritis is an autoimmune disorder in which the immune system mistakenly attacks joint tissues, causing swelling and pain.Baricitinib beat AbbVie’s drug in the study, and Lilly was widely expected to win FDA approval.In the months following the FDA’s surprise rejection of baricitinib, regulators in Europe have agreed to update the drug’s label with additional warnings for patients at risk for deep vein thrombosis and pulmonary embolism.

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