The U.S. Food and Drug Administration approved the 2-milligram dose of Eli Lilly and Co. and Incyte Corp.'s rheumatoid arthritis drug Olumiant.
Olumiant, or baricitinib, is a once-daily oral medication to treat adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor, or TNF, inhibitor therapies.
The FDA approved Olumiant with a boxed warning, the agency's most prominent warning, for the risk of serious infections leading to hospitalization or death.
According to a press release, there have been cases of certain infections, including tuberculosis and bacterial, invasive fungal and viral, among others in patients. Patients treated with the drug have also seen instances of lymphoma and other malignancies.
In addition, treatment with the drug has resulted in the formation of blood clots in certain cases, some of which have been fatal.
The approval of the 2-miligram dose, which was supported by a committee of the FDA, is based on a phase 3 clinical trial in 527 patients that showed that patients treated with the drug had significantly higher rates of a 20% improvement in their disease compared to placebo-treated patients at week 12.
Olumiant also showed early symptom relief, with patients seeing a 20% improvement as early as the first week of treatment.
As part of the approval, Lilly and Incyte agreed to conduct a trial to evaluate the long-term safety of the drug in patients with rheumatoid arthritis.
Lilly plans to launch the treatment, which will be 60% cheaper than the leading TNF inhibitor, in the U.S. by the end of the second quarter. The company will also offer a patient support program, dubbed Olumiant Together.
Due to the approval, Incyte is now eligible to receive a $100 million milestone payment from Lilly, which it expects to recognize in the second quarter.
