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FDA extends review period for baricitinib

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The FDA has extended their review period of the new drug application for Eli Lilly’s baricitinib, a once-daily treatment for rheumatoid arthritis, according to a company press release.

“At Lilly, we are committed to improving the lives of people with life-long chronic diseases, such as rheumatoid arthritis, a serious and disabling type of arthritis,” J. Anthony Ware, MD, senior vice president, product development and interim president of Lilly Bio-Medicines, said in the release. “We will continue to work closely with the FDA throughout the review process and we believe that baricitinib has the potential to be an effective treatment choice, especially for those patients for whom current therapies are not adequately addressing their disease.”

The FDA extended the date of the new drug application (NDA) — which was initially submitted in January 2016 — to review additional data that were recently submitted by Lilly in response to information requests by the FDA. The FDA deemed this submission to constitute a major amendment to the NDA that will result in an extension of the Prescription Drug User Fee Act goal date by 3 months.

Reference:

https://investor.lilly.com/releasedetail.cfm?ReleaseID=1007957