Drug Development, Regulatory

Eli Lilly gets a date with FDA experts for once-rejected rheumatoid arthritis drug baricitinib

Eli Lilly’s one-time blockbuster hopeful baricitinib $LLY is back and on track and ready to run a gamut of outside experts at the FDA.

The agency is calling a session of its arthritis advisory committee on April 23rd to weigh in on Lilly’s application, which was given a stunning rejection for safety issues last year that derailed the pharma giant’s earlier promise of scoring two new drug approvals a year.

According to Lilly, the FDA rejected the drug last April after noting regulators’ concerns about thromboembolic events — clotting — in 2 of 7 studies that raised an alarm. Lilly, though, completely disagreed with the agency’s position on safety while insisting that there was nothing aberrant about the rate of clots.

In a different regime, that would likely have left baricitinib hanging, waiting years for new trial data to satisfy the FDA. But instead Scott Gottlieb was dispatched to the FDA soon after as the new commissioner, and Lilly was one of three companies that swiftly earned a new review after the FDA dropped their study demands. (The other two were TherapeuticsMD and Amicus.)

Analysts had expected Lilly to make this into a $2 billion franchise before the rejection. But those numbers may have changed, as the RA business remains one of the most competitive fields in biopharma.


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