Healthcare company Eli Lilly and Company, Incyte Corporation and The Lupus Research Alliance on Friday jointly announced the receipt of US Food and Drug Administration (FDA) fast track designation to facilitate the development and expedite the review of baricitinib for the treatment of systemic lupus erythematosus (SLE).
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. The immune system, which is designed to protect against infection, creates antibodies, can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin and joints
The positive results from the Phase 2 study of baricitinib for the treatment of SLE were presented at the European Congress of Rheumatology (EULAR) and published by The Lancet.
In conjunction, Lilly is currently conducting two Phase 3 SLE trials to test two doses of baricitinib. Baricitinib is currently approved in the US and 50 countries throughout the world as a treatment for rheumatoid arthritis under the brand name OLUMIANT.
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