The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Eli Lilly and Company and its partner, Incyte, a Wilmington, Delaware-based biopharmaceutical company, for their new drug application (NDA) of baricitinib, an investigational oral medication for treating moderate-to-severe rheumatoid arthritis (RA), indicating that the FDA is unable to approve the application in its current form. The FDA is specifically seeking additional clinical data to determine the most appropriate doses of the drug and to further characterize safety concerns across treatment arms.

Lilly and Incyte submitted the NDA for baricitinib to the FDA in January 2016, and in January 2017 announced that the FDA’ provided a three-month extension to allow time for review of additional data analyses.

Baricitinib, a Janus kinase (JAK) inhibitor currently in clinical studies for inflammatory and autoimmune diseases, has been forecast by some analysts to be a future blockbuster. The drug was recently approved in the European Union under the brand name Olumiant (baricitinib) in 4-mg and 2-mg dose tablets by the European Commission in February 2017 for treating moderate-to-severe active RA. The drug is currently being studied in Phase II trials for atopic dermatitis and systemic lupus erythematosus, and a Phase III trial for psoriatic arthritis is expected to be initiated in 2017.

Lilly and Incyte, which entered a license agreement in December 2009 to develop and commercialize baricitinib, have said that they disagree with the FDA’s conclusions and that the timing of a resubmission will be based on further discussions with the agency. Lilly has reaffirmed both its financial guidance for 2017 and its mid-term guidance for the remainder of this decade, and Incyte is evaluating the impact of the CRL on its previously issued milestone and research and development expense guidance for 2017.

Source: Eli Lilly and Company