Lilly to File Baricitinib Resubmission to US FDA before end of January 2018.
M2 PHARMA-September 1, 2017-Lilly to File Baricitinib Resubmission to US FDA before end of January 2018
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- US-based pharmaceutical company Eli Lilly and Co (NYSE: LLY) and Incyte Corp. (NASDAQ: INCY) announced TODAY that, after discussions with the US Food and Drug Administration in late August,
US-based pharmaceutical company Eli Lilly and Co (NYSE: LLY) will resubmit the New Drug Application for baricitinib before the end of January 2018, after discussions with the US Food and Drug Administration in late August, the company said.
The resubmission package will include new safety and efficacy data.
Lilly and partner Incyte Corp. (NASDAQ: INCY) anticipate 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.
It is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases.
There 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.
In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialisation of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the US, the European Union and Japan in 2016.
Baricitinib was approved in the EU in February 2017 and in Japan in July 2017. In April 2017, the US Food and Drug Administration issued a Complete Response Letter on the New Drug Application for baricitinib. Baricitinib remains under review in other markets. It is also being studied for the treatment of atopic dermatitis and systemic lupus erythematosus.
The Phase 3 programme for psoriatic arthritis is expected to begin in 2018.
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|Date:||Sep 1, 2017|
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