04Lilly, Incyte arthritis drug gets FDA approval
Eli Lilly and Company and Incyte Corporation, Wilmington, announced that the U.S. Food and Drug Administration has approved Olumant (baricitinib The once-daily oral medication is approved for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have not responded to a commonly used therapy.
Patients treated with Olumant reported significant improvements in physical function based on the Health Assessment Questionnaire Disability Index.
Olumant is approved with a Boxed Warning for the risk of serious infections, malignancies and thrombosis. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients.
“Despite the advancements we’ve seen in the RA treatment landscape over the past several decades, many patients are still failing to achieve their disease management goals,” said Seth Ginsberg, co-founder and president of CreakyJoints and the Global Healthy Living Foundation. “As it’s important for RA patients to have multiple treatment options available to best suit their disease characteristics and experiences, the approval of Olumant is very encouraging for our community.”
“In my clinical practice, I continue to see patients who experience debilitating symptoms and who are waiting for a medicine that may be right for them,” said Elizabeth L. Perkins, M.D., of the Rheumatology Care Center, Birmingham, AL. ” Olumant is an important option for rheumatologists to help address these patients’ unmet needs.”
“RA patients continue to experience unique challenges accessing the treatments prescribed by their healthcare providers. 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,” said Shaw.
Lilly will launch Olumant in the U.S. by the end of the second quarter of 2018. The price of Olumant will be 60 percent less than the leading TNF inhibitor.
Incyte is now eligible to receive a $100 million milestone payment from Lilly as a result of the Olumant approval.
