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Lilly & Incyte partnership to file Baricitinib Resubmission for the treatment of rheumatoid arthritis with US FDA.

M2 EQUITYBITES-August 31, 2017-Lilly & Incyte partnership to file Baricitinib Resubmission for the treatment of rheumatoid arthritis with US FDA


Healthcare company Eli Lilly and Company (NYSE:LLY) and Incyte Corporation (NASDAQ:INCY) stated on Wednesday that they will resubmit the New Drug Application (NDA) for baricitinib with the US Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis before the end of January 2018.

The companies added that the resubmission package will include new safety and efficacy data. The FDA will classify the application as a Class II resubmission, which will start a new six-month review cycle. Baricitinib is a once-daily oral investigational medication for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA).

According to the companies, Baricitinib is a once-daily oral JAK inhibitor and are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions, including rheumatoid arthritis, a systemic autoimmune disease characterised by inflammation and progressive destruction of joints.

In conjunction with the NDA, the companies conducted four successful pivotal Phase 3 clinical trials of baricitinib in patients with moderate-to-severe active rheumatoid arthritis to support regulatory submission in most countries.

Two of the four studies included pre-specified comparisons to approved DMARDs: one to methotrexate (RA-BEGIN) and one to adalimumab (RA-BEAM). An additional phase 3 study recently concluded to support clinical development in China, concluded the companies.

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Publication:M2 EquityBites (EQB)
Date:Aug 31, 2017
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