The recent first global approval of Baricitinib has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.
In February 2017, baricitinib (Olumiant™), developed by Eli Lily and Incyte Corporation, received its first global approval in the EU as monotherapy or in combination with methotrexate, for the treatment of moderate to severe rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Baricitinib is an orally administered, small molecule, janus-associated kinase (JAK) inhibitor that transduces intracellular signals from cell surface receptors for various cytokines and growth factors involved in inflammation and immune function.
The prevalence of rheumatoid arthritis varies by region, but affects up to 1% of the population worldwide and is three times more common in women than men.1 A satisfactory response to the most effective of available treatments is lacking in more than half of patients with rheumatoid arthritis2 , therefore, alternative treatment options to DMARDS are necessary.
Baricitinib is the first JAK inhibitor to be approved in the EU and joins the small but expanding set of alternative MOA agents emerging globally. The competition within this group of agents is expected to be high; the once-daily oral formulation will provide a competitive edge for baricitinib with regard to patient preference.2
J. Anthony Ware, M.D., senior vice president for product development and interim president, Lilly Bio-Medicines, said:
“Despite clinical advances in treatment, many people with RA continue to struggle with the debilitating effects of this disease, which can lead to long-term joint damage and disability,”
“We believe that as a next-generation therapy in the EU, Olumiant will advance RA treatment by helping patients with moderate-to-severe disease feel better quickly” 3
Baricitinib is also under phase II investigation for the treatment of systemic lupus erythematosus, and is awaiting approval in the US and Japan for rheumatoid arthritis.