“In immunology, we're looking forward to potential FDA approvals later this year for mirikizumab in ulcerative colitis, which we expect in the first half of the year and lebrikizumab in atopic dermatitis, which we expect in the second half of the year.”

In context

“tudy imlunestrant in the adjuvant setting. As a sequential monotherapy in patients who previously received two to five years of adjuvant endocrine therapy for ER-positive HER2-negative early breast cancer with increased risk of recurrence. Lastly turning to Verzenio. As noted in our guidance call at the San Antonio Breast Cancer Symposium in December, we shared the latest interim analysis for monarchE, our adjuvant high-risk early breast cancer study of abemaciclib in combination with endocrine therapy for the treatment of adult patients with HR-positive HER2-negative node positive early breast cancer at high risk of recurrence. We've now submitted an sNDA to the US FDA to potentially expand our adjuvant indication beyond the currently indicated Cohort 1 KI-67 greater than 20% population. In immunology, we're looking forward to potential FDA approvals later this year for mirikizumab in ulcerative colitis, which we expect in the first half of the year and lebrikizumab in atopic dermatitis, which we expect in the second half of the year. Looking earlier in our immunology pipeline, as mentioned in our guidance call, we presented exciting proof-of-concept results for our PD-1 agonist antibody peresolimab in rheumatoid arthritis at the ACR conference in November and we have now initiated a global dose-ranging Phase IIb study. Moving to neuroscience. We've advanced into Phase II our P2X7 inhibitor for chronic pain. Lilly acquired rights to this asset from Asahi Kasei Pharma in early 2021. With regards to donanemab. As Dave mentioned, the sole efficiency cited by the FDA to our submission for accelerated approval was a number of patients with at least 12 months of drug exposure. The Phase II TRAILBLAZER-ALZ trial on which the accelerated approval application was based, allowed patients to complete their course of treatment wit”