FDA’s insider review raises serious safety issues as Eli Lilly’s quick comeback shot for baricitinib heads for expert showdown
Eli Lilly $LLY has got some explaining to do.
And unlike the FDA, which abruptly reversed course on their rejection of Lilly’s baricitinib for rheumatoid arthritis without ever fully outlining the reasons for the about-face, there’s no getting around the challenge for the pharma giant.
It’s clear from the agency’s internal review, which includes conflicting conclusions from different FDA officials on the safety and benefit of the drug, that the agency had a big problem with evidence that Lilly’s drug triggered thrombosis in patients. Like any powerful immune suppressant, the Lilly drug was linked with a variety of related symptoms, but thrombosis — dangerous blood clotting — is not common to the class.
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