The recent First Global Approval of baricitinib in the EU has been reviewed in detail in the First Global Approval report in Adis journal Drugs based on the development milestones tracked in AdisInsight.
In July, 2017, baricitinib (Olumiant™), developed by Eli Lily and Incyte Corporation, was also approved in Japan as 2-mg and 4-mg tablets for the treatment of rheumatoid arthritis (RA) (including the prevention of structural injury of joints) in patients with inadequate response to standard-of-care therapies.
“Today is an important milestone for the RA community in Japan. Olumiant has been shown to provide effective relief of RA symptoms in people who do not respond to standard treatments, as well as prevent the structural damage to joints that makes RA a progressive, debilitating disease,” said Christi Shaw, president of Lilly Bio-Medicines.
However, baricitinib is still awaiting approval in the US. In April, 2017, the US FDA issued a complete response letter citing the need for additional safety data for the drug as well as further clinical data to determine the most appropriate dosage.
“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,” said Christi Shaw, president of Lilly Bio-Medicines.
The company is continuing to work with the FDA to facilitate access of baricitinib to patients in the U.S.
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