In a stunning setback, FDA spurns Eli Lilly’s marketing application for baricitinib, demands more data
The FDA has rejected Eli Lilly’s blockbuster contender baricitinib, saying that the pharma giant will need to gather significantly more data before regulators will reconsider their decision.
According to a statement from Lilly, the pharma giant will not only need to provide more clinical data on the appropriate doses to be used for rheumatoid arthritis, regulators are also demanding more safety data, which could significantly delay any response to the CRL. Lilly says it disagreed with the FDA’s conclusion and the rejection.
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