The U.S. Food and Drug Administration (FDA) has extended the review period for a new drug application (NDA) for Eli Lilly’s investigational treatment baricitinib for rheumatoid arthritis (RA).
The announcement was made by Eli Lilly and Incyte Corporation.
The FDA decided to extend the review period for more time to analyze additional data submitted by the companies based on the results of a Phase 3 trial (NCT02265705). The additional data was submitted in response to the FDA’s request for information. The FDA considered this data would lead to a major amendment to the NDA, which resulted in the extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months.
The NDA for baricitinib was submitted in January 2016 for a once-daily oral medication for the treatment of moderate-to-severe RA.
Baricitinib is recommended for those who fail to respond to, or are unable to tolerate, disease-modifying anti-rheumatic drugs (DMARDs). Baricitinib is a janus oral kinase (JAK) 1 and 2 inhibitor. Janus kinases are enzymes that transmit important cell signals involving a number of proteins known as cytokines and growth factors in blood-cell formation, inflammation, and immune function.
After Lilly submitted the FDA application seeking marketing approval in the U.S., baricitinib received a positive opinion in December 2016 by the European Medicines Agency (EMA) recommending its approval. If approved, the drug will be marketed as Olumiant.
The two clinical trials supporting the regulatory submissions were RA-BUILD (NCT01721057) and RA-BEAM (NCT01710358).
“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 of product development and interim president of Eli Lilly Biomedicines, said in a press 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.”
Lilly and Incyte partnered in 2009 to develop baricitinib as a treatment for inflammatory and autoimmune diseases, including RA. Eli Lilly will pay Incyte $65 million in an up-front payment after the EU grants marketing authorization to the therapy.
