In documents released Thursday ahead of an FDA advisory committee meeting, agency staff raised concerns over the risk of thrombosis linked to higher doses of Eli Lilly and Incyte's Olumiant (baricitinib). The companies are seeking approval of the drug for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or are intolerant to methotrexate.
The original filing for Olumiant was made in 2016, although the FDA rejected the application in April last year because the drug's overall benefit-risk assessment was not favourable. Eli Lilly and Incyte resubmitted the filing in last December.
Ahead of the advisory committee meeting on April 23, FDA reviewers also flagged the proposed dosing strategy for Olumiant, noting that it "is more complicated and deviates from labelling" for other non-biologic disease-modifying antirheumatic drugs. "This is also problematic, given that the clinical development programme was not designed to support the proposed dosing strategy," the staff said.
According to agency staff, the safety data support approval of the 2-mg dose, but not the 4-mg dose, raising concerns regarding whether the higher dose provides a clinical benefit. The reviewers also noted that the limited available data for the lower dose complicated its assessment of the risk/benefit profile of Olumiant.
Commenting on the news, Hilliard Lyons analyst Kurt Kemper stated "at this point, approval in the US is in jeopardy," noting that the review was harsher than anticipated. Meanwhile, Evercore ISI analyst Josh Schimmer suggested that questions over the doses could lead to an "awkward" drug label.
Additionally, BMO Capital Markets analyst Alex Arfaei cautioned "we doubt the [advisory committee] will alleviate the FDA's safety concerns since they typically take a conservative approach, particularly when there is not a dire unmet need." Moreover, Credit Suisse analysts suggested "this could be a positive for competitors such as AbbVie and Gilead [Sciences] and Galapagos that have their own oral JAK inhibitors in late-stage development."
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