Shots:
The P-III (LUCENT-2) maintenance study evaluated the safety & efficacy of mirikizumab vs PBO in 365 active ulcerative colitis patients with 12wks completion of LUCENT-1 study, require maintenance therapy & with previously failed conventional/biologic therapies/JAK inhibitors
The results demonstrated superior endpoints of mirikizumab vs PBO as 50% (~182/365) vs 25.1% (~45/179) of patients achieved clinical remission in 1yr. with the maintenance of clinical remission in 63.6% (~91/143) vs 36.9% (~24/65)
The study showed a constant OS & fewer AEs vs PBO. Additionally, Lilly has submitted a BLA to the US FDA & an MAA in the EU for the approval of mirikizumab with regulatory decisions expected in 2023
Ref: PRNewswire | Image: Lilly
