The US Food and Drug Administration (FDA) has approved a lower dose of Olumiant (baricitinib), a daily once oral Janus kinase inhibitor produced by Lilly and Incyte intended to treat moderately-to-severely active rheumatoid arthritis (RA), it was reported yesterday.
The approval is for a 2mg dose of the drug in adult patients who did not indicate adequate response to one or more tumour necrosis factor inhibitor therapies. The product has been indicated to be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs. However, the drug is not recommended to be used in combination with other JAK inhibitors or biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. The product's approval was driven by the findings of a phase three clinical trial program that showed efficacy of the JAK inhibitor for difficult to treat rheumatoid arthritis patients.
Lilly said that it plans to launch Olumiant in the US by the end of the second quarter of this year.
Following the FDA approval, Incyte, which had licensed the RA drug to Lilly, will be eligible to receive a milestone payment of USD100m from the latter.
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