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Eli Lilly and Company and Incyte Corporation announced today that, after discussions with the U.S. Food and Drug Administration (FDA) in late August 2017, Lilly will resubmit a revised New Drug Application (NDA) for baricitinib before the end of January 2018. The resubmission package will include new safety and efficacy data.
The resubmission will address the FDA's July 2017 concerns about safety, especially the "imbalance in thromboembolic events" only seen with the 4 mg dose, during the placebo-controlled period of the rheumatoid arthritis (RA) development trials.
The companies anticipate the FDA will classify the application as a Class II resubmission, which will start a new six-month review cycle. This is a dramatic change from prior projections that anticipated an 18 month delay in resubmission and a projected drug launch in 2021.
Baricitinib is a once-daily oral investigational medication for the treatment of patients with moderate-to-severe RA. Baricitinib is a potential competitor to Pfizer's Xeljanz (tofacitinib), whose sales are up more than 40% and project to be greater than $1 billion in 2017. In development are two other Jak inhibitors: filgotinib (Gilead Sciences) and upadacitinib (AbbVie).
It remains to be seen if the 2 mg or 4 mg dose (or both) will be accepted by the FDA for safe use.