Major Amendment to baricitinib NDA sets back FDA review three months

16 January 2017

US pharmaceutical companies Eli Lilly (NYSE: LLY) and Incyte (Nasdaq: INCY) have announced that the US Food and Drug Administration has extended by three months the action date for its review of their rheumatoid arthritis (RA) candidate baricitinib.

The FDA determined that supplementary data submissions from Lilly constituted a Major Amendment to the New Drug Application (NDA), necessitating further time for analysis.

Those submissions were made in response to certain information requests from the American regulator regarding the NDA, which was submitted in January 2016.

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