Lilly posts ACHIEVE-J results; Olumiant, Strattera labels updated

Five Lilly-linked records updated recently, led by posted results from a completed diabetes safety study.

• Orforglipron (LY3502970) is the subject of ACHIEVE-J, a phase 3 long-term safety study in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone or in combination with oral antihyperglycemic medications.¹ The study is now completed, with sites 40 sites in 1 country: Japan.¹ Results showed treatment-emergent adverse events in 107 participants on 3 mg orforglipron, 114 on 12 mg, and 118 on 36 mg, with serious adverse events in 4 of 132 participants on 3 mg, 3 of 135 on 12 mg, and 6 of 134 on 36 mg.¹ Total enrollment was 401 participants (actual).¹
• Olumiant (baricitinib), an oral tablet available in 1MG, 2MG, and 4MG strengths,² received a labeling supplement approval, submission class Labeling, submission number 11, with status AP (approved), and an approval letter dated 20260702, with a label and medication guide dated 20260710.²
• Strattera (atomoxetine hydrochloride) also had a labeling supplement approved, covering capsule strengths of 80MG, 40MG, 18MG, 5MG, 100MG, 60MG, 25MG, and 10MG base equivalents.³ The supplement, submission number 53, was approved with status AP, with an approval letter dated 20260702 and an updated label and medication guide dated 20260710.³
• Vepugratinib (LY3866288), an oral FGFR3 inhibitor, opened an expanded access program, sponsored by Eli Lilly and Company, for Urinary Bladder Neoplasms; Neoplasm Metastasis; Carcinoma, Transitional Cell.⁴ Eligible patients must have metastatic urothelial carcinoma (UC) or other solid tumor with a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration, and must have exhausted other approved treatments, including erdafitinib for UC.⁴
• Abemaciclib, a CDK4/6 inhibitor, is the subject of the TRADE study, a phase 2 trial sponsored by Dana-Farber Cancer Institute, with Eli Lilly and Company as collaborator.⁵ The trial, which enrolled 90 participants (actual),⁵ is now active not recruiting,⁵ and tests a dose-increasing strategy for abemaciclib to see if it will have less side effects and be better tolerated than the standard dosage for participants with early-stage high-risk hormone receptor positive breast cancer.⁵