Eli Lilly, Incyte set to resubmit Olumiant for FDA approval earlier than expected

Eli Lilly and Incyte announced Wednesday that following talks with the FDA, they will resubmit an application seeking approval of Olumiant (baricitinib) for the treatment of patients with moderate-to-severe rheumatoid arthritis before the end of January 2018. The companies said that they expect the agency to classify the filing as a Class II resubmission, which will start a new six-month review cycle.

In July, Eli Lilly and Incyte indicated that a resubmission for Olumiant would be delayed by at least 18 months, after the FDA rejected the initial filing in April. The regulator had asked for more clinical data to determine the most appropriate doses for the once-daily oral JAK inhibitor, as well as additional data to further characterise safety concerns.

FirstWord reports in this therapy area - KOL Insight Rheumatoid Arthritis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

According to Eli Lilly and Incyte, the resubmission package for Olumiant will include new safety and efficacy data. "We are pleased with the opportunity to provide our resubmission package for [Olumiant] sooner than anticipated," remarked Christi Shaw, president of Lilly Bio-Medicines.

The drug was approved in the EU in February, while gaining clearance in Japan in July.

For related analysis, see Physician Views: Xeljanz more compelling than Olumiant for psoriatic arthritis; Olumiant delay likely to have neutral impact on Xeljanz use in RA.

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