Autoimmune diseases company Eli Lilly and Company (NYSE:LLY) said on the US Food and Drug Administration's (FDA) fast track designation to facilitate the development and expedite the review of baricitinib for the treatment of systemic lupus erythematosus (SLE) in partnership with Incyte Corporation (NASDAQ:INCY).
Systemic lupus erythematosus (SLE) is a chronic, multi-organ autoimmune disease that can cause widespread tissue and organ damage. SLE is characterized by periods of flare and remission and is associated with a variety of symptoms, including extreme fatigue, unexplained fever, joint pain/swelling and butterfly rash.
Additionally, Lilly is currently studying two doses of baricitinib in Phase 3 SLE trials as well as investigating baricitinib as a potential treatment for moderate to severe atopic dermatitis, a serious form of eczema, with Phase 3 results projected to be shared during the first half of 2019.
According to the company, Baricitinib is approved in over 50 countries globally as OLUMIANT (baricitinib) in 2mg for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial