US regulatory advisors are backing approval of the lower dose form of Eli Lilly and Incyte’s once-daily JAK inhibitor baricitinib as treatment for rheumatoid arthritis (RA).
The US Food and Drug Administration’s Arthritis Advisory Committee recommended approval of the 2-mg dose of the drug for moderately-to-severely active RA in adults who have had an inadequate response or intolerance to methotrexate.
However, while the Advisory Committee unanimously supported the efficacy of the 4-mg dose of baricitinib, it did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles, Lilly noted.
"We are confident that baricitinib, if approved, can help people in the US 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 approved in more than 40 countries, including the member states of the European Union and Japan.