A once-daily treatment for rheumatoid arthritis being developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY) and Delaware-based Incyte Corp. (Nasdaq: INCY) has cleared a key hurdle. The U.S. Food and Drug Administration has approved Olumiant following several years of clinical trials.
Lilly says the treatment, also known as baricitinib, has been approved for adults with moderately-to-severely active RA, who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies. Christi Shaw, president of Lilly Bio-Medicines says Olumiant will provide an effective treatment option as these types of RA patients "are generally considered to be some of the most difficult to treat."
"RA patients continue to experience unique challenges accessing the treatments prescribed by their healthcare providers," added Shaw. "Therefore, we are determined to continue our work with stakeholders to demonstrate value across the healthcare system so providers have greater choice in prescribing treatments to fit individual patient needs."
The pharmaceutical giant says it will launch Olumiant in the U.S. by the second quarter of 2018. The FDA approval also means Incyte is eligible to receive a $100 million milestone payment from Lilly, which is expected to occur in the second quarter as well.
Lilly re-submitted its New Drug Application with the FDA in August after initially being rejected earlier in the year. Olumiant received approval from the Japan Ministry of Health, Labor and Welfare last July.