Tags : baricitinib

Eli Lilly Signs a Clinical Trial Collaboration with NIH to

Shots: The clinical research commences in NIH-led Adaptive COVID-19 Treatment Trial and will evaluate the efficacy and safety of baricitinib for hospitalized patients diagnosed with COVID-19, initiating this month in the US with a planned expansion to additional sites including EU and Asia Additionally, Lilly will advance its LY3127804 (mAb against Ang2) to P-II study […]Read More

Eli Lilly and Incyte’s Olumiant (baricitinib) Receives the US FDA’s

Shots: The FDA’s BT designation is based on P-II results of P-II/III BRAVE-AA1 study assessing baricitinib vs PBO in patients with AA The P-II portion of the BRAVE-AA1 study demonstrated no new safety signals with no SAEs @36wks. Additionally, P-III portion of BRAVE-AA1 & P-III BRAVE-AA2 study, are currently evaluating baricitinib (2mg/4mg) vs PBO in […]Read More

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) +

Shots: The P-III BREEZE-AD7 study involves assessing of Olumiant (2mg, 4mg) + SOC topical corticosteroids vs PBO in patients with moderate to severe atopic dermatitis for 16wks. The P-II BREEZE-AD program is expected to be completed in 2019 The P-III BREEZE-AD7 study results: met its 1EPs @16wks. i.e, (vIGA 0, 1) score of “clear or […]Read More

Eli Lilly Reports Results of Olumiant (baricitinib) in P-III BREEZE-AD1

Shots: The two P-III study BREEZE-AD1 and BREEZE-AD2 involves assessing of baricitinib vs PBO in patients with moderate-to-severe AD The two P-III study resulted in meeting 1EPs @16 wks. with no venous thromboembolic events (VTEs), major adverse cardiovascular events (MACE) & deaths rates Olumiant (baricitinib, 2mg) indicated for moderate-to-severe RA who have had an inadequate […]Read More

Eli Lilly’s Olumiant (baricitinib) Receives FDA’s Fast Track Designation for

Shots: The FDA’s designation is based on P-II study results assessing Baricitinib in patients with SLE, presented at European Congress of Rheumatology 2018 Lilly is also evaluating baricitinib’s two doses in P-III SLE trials and for moderate-to -severe atopic dermatitis, with its expected results in H1’19 Olumiant (baricitinib) 2mg is an inhibitor of janus kinase, further blocking […]Read More

Eli Lilly’s Olumiant (baricitinib) Receives FDA Approval for Moderately-to-Severely Active

Shots: The approval is based on P-III RA-BEACON study results assessing Olumiant vs PBO in 527 patients with inadequate response or intolerance to one or more TNF inhibitor therapies P-III RA-BEACON study results: ACR20 (49% vs 27%) physical function based on the Health Assessment Questionnaire Disability Index (HAQ-DI) before/ after treatment (1.71, 1.78/ 1.31, 1.59) […]Read More