Eli Lilly and Company and Incyte Corporation announced that the U.S. Food and Drug Administration’s Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of rheumatoid arthritis.
The lower does be recommended for adult patients who have had an inadequate response or intolerance to methotrexate. However, the panel did not recommend a higher dose.
Incyte shares were down eight percent in trading on Tuesday and recorded a portion of that loss on Wednesday. It was the second piece of disappointing news for the Wilmington-area company. Earlier, a trial on a combination of cancer drugs was halted after no positive findings were reported.
While the Advisory Committee unanimously supported the efficacy of the 2-mg dose of baricitinib, it did not recommend approval of the 4-mg dose of baricitinib based on safety profiles.
“We are confident that baricitinib, if approved, can help people in the U.S. manage the challenges of living with RA,” said Christi Shaw, president of Lilly Bio-Medicines. “While we are disappointed with the Advisory Committee’s assessment of the data for the 4-mg dose, we are confident in the positive benefit-risk profile of both the 2-mg and the 4-mg doses. We look forward to continuing our work with the FDA on our New Drug Application (NDA) and are hopeful that baricitinib will receive approval in the coming months.”
Baricitinib 2-mg and 4-mg doses are already approved in more than 40 countries, including the member states of the European Union and Japan.
“Despite advances in the management of RA over the last 20 years, which include early treatment, optimized use of traditional therapies for rheumatic disease and the advent of newer medications such as biologics, many patients are still struggling to meet treatment targets, and live with debilitating pain, fatigue and other symptoms of RA,” said Peter Taylor, MA, PhD, professor, University of Oxford, an expert who attended the Advisory Committee Meeting. “Baricitinib could be a promising option for RA patients in the U.S. who are not achieving adequate disease control with currently available treatments.”
The FDA is not required to follow the Advisory Committee’s recommendation but will consider it during its review of the NDA for baricitinib.
In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
