U.S. regulators want additional dosing- and safety-related information before they will approve Eli Lilly and Incyte‘s New Drug Application (NDA) request for the rheumatoid arthritis (RA) treatment baricitinib.
It is the second time the Food and Drug Administration has asked for additional information on baricitinib to treat moderate-to-severe rheumatoid arthritis, and the companies expressed disappointment.
Regulators said they needed more information to help them determine appropriate doses, and they also wanted to know more about baricitinib’s safety across different treatment arms.
Lily and Incyte announced an exclusive worldwide collaboration and licensing agreement in December 2009 to develop and commercialize baricitinib.
“We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA,” Christi Shaw, president of Eli Lilly Bio-Medicines, said in a press release. “We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.”
The companies submitted the NDA in January 2016. They announced this January that the FDA had extended the Prescription Drug User Fee Act for three months, giving it more time to review additional data. The companies submitted the data in response to the FDA’s initial request for more information.
Regulators extended the review period so they would have more time to analyze additional material from the companies’ Phase 3 trial (NCT02265705).The agency had anticipated that the new data could lead to a major amendment of the NDA.
Baricitinib is a Janus oral kinase (JAK) 1 and 2 inhibitor. Janus kinases are enzymes that transmit important cell signals about proteins known as cytokines and growth factors that are involved in blood-cell formation, inflammation, and immune function.
The European Medicines Agency approved baricitinib in February to treat RA in adults who have failed to respond to, or who are intolerant of, one or more disease-modifying anti-rheumatic drugs (DMARDs).
The EU approval was supported by a four-part Phase 3 clinical trial program covering a wide range of patients. Two of the four trials compared baritcitinib with approved DMARDs. The RA-BEGIN trial (NCT01711359) compared bariticitinib with tmethotrexate, and the RA-BEAM trial (NCT01710358) with Humira (adalimumab),
Baricitinib did a better job in both trials of improving symptoms of RA. The companies plan to market the drug under the name Olumiant in Europe.