FDA quashes blockbuster dreams at Eli Lilly and Incyte, offering a severely limited approval for Olumiant
Visions of blockbuster sales for the rheumatoid arthritis drug baricitinib were quashed by the FDA’s approval today. Regulators came through with an OK for the low, 2 mg dose of the drug, to be marketed as Olumiant, spurning the 4 mg dose that they had been seeking and limiting the patient population to TNF resistant cases.
The regulatory OK also comes with a black box warning for the drug’s side effects, which includes a startling signal on thromboembolism.
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