Regulatory Affairs

FDA reject’s Eli Lilly’s NDA for rheumatoid arthritis drug baricitinib

PBR Staff Writer Published 17 April 2017

The US Food and Drug Administration has rejected Eli Lilly and Incyte’s new drug application (NDA) for investigational medicine baricitinib to treat moderate-to-severe rheumatoid arthritis (RA).

The regulator stated that the NDA requires additional clinical data to determine the most appropriate doses of the once-daily oral medication.

In addition, the FDA said additional data is required to further characterize safety concerns across treatment arms.

Baricitinib, which is a once-daily oral JAK inhibitor, is currently in clinical studies for inflammatory and autoimmune diseases.

The firms have not agreed with the conclusions of the FDA and are planning to resubmit data based on further discussions with the agency.

In January 2016, the companies submitted the NDA for baricitinib. In January this year, the FDA granted three-month extension to review additional data analyses.

JAK inhibitors are expected to be used to treat a range of inflammatory conditions, including RA.

In December 2009, both firms signed worldwide license and collaboration agreement to develop and commercialize baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

Last year, the applications for baricitnib were submitted for regulatory review seeking marketing approval to treat RA in the US, European Union and Japan. It was approved in the EU in February this year.

Baricitnib is being examined in phase 2 trials for atopic dermatitis and systemic lupus erythematosus, while phase 3 trial for patients with psoriatic arthritis is slated to begin in this year.

The firms carried out four successful pivotal phase 3 clinical trials of baricitinib in patients with moderate- to-severe active RA for regulatory submission in multiple countries.

Lilly Bio-Medicines president Christi Shaw said: "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.

"We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S."

Image: Eli Lilly headquarters. Photo: courtesy of Guanaco152003.