FDA has knocked back Eli Lilly and Incyte’s once-daily oral rheumatoid arthritis (RA) drug baricitinib, just weeks after the oral JAK1/2 inhibitor was approved in Europe under the brand name Olumiant®. Following a 3-month extension to its review period, the U.S. regulator issued Incyte and Lilly with a Complete Response Letter stating that it wanted additional clinical data to make sure of the correct dosing and to characterize safety concerns.

“We are disappointed with this action,” stated Christi Shaw, president of Lilly Bio-Medicines. “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.”

In 2009, Lilly and Incyte agreed a global license and collaboration agreement to develop baricitinib and follow-on compounds for inflammatory and autoimmune diseases. The drug is also in Phase II development for atopic dermatitis and systemic lupus erythematosus, and a Phase III study in patients with psoriatic arthritis is projected to start this year.

Incyte received a $35 million milestone payment from Lilly in January 2016 on the firms’ submission of their NDA for approval of baricitinib as a treating moderate-to-severe active RA. Incyte is due another $100 million if the agency approves the drug.

European approval of Olumiant covers use of the drug to treat moderate-to-severe active RA in adults who have responded inadequately to or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

Late last month, the European Commission approved Pfizer’s twice-daily, oral JAK inhibitor Xeljanz® (tofacitinib citrate) as combination therapy with methotrexate for treating moderate-to-severe rheumatoid arthritis (RA) in adults who haven't responded to or are intolerant to DMARD therapy.


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