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Partner : ELi Lilly

U.S. FDA Extends Review Period for Baricitinib, an Investigational Rheumatoid Arthritis Treatment
INDIANAPOLIS, Jan. 13, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug application (NDA) for investigational baricitinib, a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA). The NDA for baricitinib was submitted to the FDA in January 2016.
The FDA extended the action date to allow time to review additional data analyses recently submitted by Lilly in response to the FDA's Information Requests. The submission of the additional information has been determined by the FDA to constitute a Major Amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months.
"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," said J. Anthony Ware, M.D., senior vice president, product development and interim president of Lilly Bio-Medicines. "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."
This delay does not affect Lilly's previously-issued financial guidance for 2017.
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Source: press release, 1/13/17. http://www.incyte.com/ir/press-releases.aspx

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Lilly and Incyte Announce Submission of New Drug Application to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis

INDIANAPOLIS, Jan. 19, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announced that Lilly has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of oral once-daily baricitinib for the treatment of moderately-to-severely active rheumatoid arthritis (RA).

As a result, Incyte will receive a milestone payment of $35 million from Lilly related to the NDA submission. If baricitinib is granted U.S. regulatory approval, Incyte will receive a milestone payment of $100 million from Lilly. Incyte could earn additional global regulatory as well as sales-based milestone payments and be eligible for royalties on global net sales of baricitinib.

If approved, Lilly will lead launch and global commercialization efforts for baricitinib in RA. Lilly owns global rights to develop and commercialize baricitinib as an oral treatment for all inflammatory conditions.

This submission milestone will result in a first-quarter charge to Lilly's GAAP and non-GAAP research and development expense of $35 million (pre-tax). Lilly's previously-issued 2016 GAAP and non-GAAP EPS guidance of $2.92-$3.02 and $3.45-$3.55, respectively, remain unchanged.
"Lilly's collaboration with Incyte has produced a rigorous phase 3 program and, if approved, the potential of a promising new treatment option for people with RA," said David Ricks, president of Lilly Bio-Medicines.
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Source: press release, 1/19/16. http://www.incyte.com/ir/investor-overview/press-releases/

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Baricitinib (INCB-28050) (LY3009104) RARheumatologyRheumatoid Arthritis (RA)Janus-associated Kinase InhibitorsJanus -associated Kinase

Mechanism of action: Baricitinib (INCB-28050) is a SM-inhibitor, reduces inflammation by disrupting the signaling of IL-6, IL-12, and IL-23 through the Janus-associated kinases (JAK) signaling pathway.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2017-04-19

Results: Pending