Eli Lilly & Co. develops and commercializes medicines across cardiometabolic disease, oncology, immunology, neuroscience and genetic medicine. Company news commonly covers product and pipeline developments for medicines such as Mounjaro, Zepbound, Foundayo, Omvoh, Verzenio, Jaypirca and Taltz, including clinical data, regulatory approvals and treatment-indication updates.
Lilly updates also include operating results, financial guidance, dividends, business development agreements and manufacturing expansion. Recent company communications highlight investment in active pharmaceutical ingredient capacity and genetic medicine production, alongside recurring disclosures about demand for diabetes, obesity, immune-disease and cancer therapies.
Eli Lilly and Company (NYSE: LLY) has announced promising results from the Phase 3 monarchE trial for Verzenio® (abemaciclib) in treating high-risk early breast cancer. The study demonstrated a statistically significant improvement in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) after a median follow-up of 27 months. At three years, IDFS improved by 5.4%, while DRFS improved by 4.2%. The data suggests that adding Verzenio to endocrine therapy could revolutionize treatment for patients at high risk of recurrence. Safety profiles remained consistent with known data.
Eli Lilly's Verzenio® (abemaciclib) has received FDA approval for the adjuvant treatment of adult patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This marks it as the first CDK4/6 inhibitor approved for this indication. The approval stems from the positive results of the monarchE trial, demonstrating a statistically significant improvement in invasive disease-free survival (IDFS) among patients treated with Verzenio in combination with endocrine therapy.
Eli Lilly and Company (NYSE: LLY) will announce its third-quarter 2021 financial results on October 26, 2021. A conference call will follow at 9 a.m. Eastern time for discussing performance details with investors and media. The call will be accessible via webcast on Lilly's website, with a replay available afterwards. Established over a century ago, Lilly continues to focus on improving global health through innovative medicines and community engagement. For more information, visit www.lilly.com.
Loxo Oncology at Lilly has announced the preclinical characterization of two new cancer agents, LOXO-783 and LOXO-435, to be presented at the 2021 AACR-NCI-EORTC Virtual Conference. Both drugs are designed for specific cancer mutations, with LOXO-783 targeting PI3Kα H1047R mutations and LOXO-435 focusing on FGFR3. IND applications for both are planned in 2022. CEO Jacob Van Naarden emphasized their potential to enhance efficacy and tolerability compared to existing treatments.
Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced the launch of CRMSynced™, an educational initiative aimed at enhancing the understanding of cardio-renal-metabolic (C-R-M) conditions among healthcare professionals.
This innovative program uses gamification to engage HCPs, addressing conditions that lead to 20 million deaths annually in the U.S. By promoting a holistic approach, CRMSynced seeks to empower practitioners to collaborate effectively, ultimately improving patient outcomes in managing interconnected diseases like diabetes and chronic kidney disease.
Eli Lilly and Company (NYSE: LLY) reported that patients with moderately to severely active ulcerative colitis achieved symptomatic remission for up to two years in a Phase 2 study of mirikizumab. Notably, 75.6% of patients maintained remission at 104 weeks. The study observed that 85.9% of participants achieved rectal bleeding remission, and 84.6% reached stool frequency remission. The safety profile of mirikizumab remained consistent with previously published data, and no new safety signals were noted. Results will be presented at UEG Week from October 3-5, 2021.
Eli Lilly and Incyte announced significant results from two pivotal Phase 3 trials (BRAVE-AA1 and BRAVE-AA2) for OLUMIANT (baricitinib) in treating severe alopecia areata. The once-daily 4-mg dose demonstrated superior scalp hair regrowth compared to placebo, with 35.2% of patients achieving over 80% scalp coverage at 36 weeks. The 2-mg dose also showed notable improvements. OLUMIANT has received Breakthrough Therapy designation from the FDA, and a supplemental New Drug Application is planned. The drug has an established safety profile with manageable side effects, underscoring its potential in addressing this unmet medical need.
Eli Lilly's tirzepatide showed superior efficacy in reducing liver fat and abdominal adipose tissue compared to insulin degludec in adults with type 2 diabetes, according to findings from the SURPASS-3 MRI sub-study presented at the EASD Annual Meeting. The study, involving 296 participants, demonstrated significant reductions in liver fat content (LFC) with tirzepatide doses (up to -8.09%) against insulin degludec (-3.38%). Additionally, a larger percentage of tirzepatide participants achieved at least a 30% reduction in LFC (up to 81.4%) versus insulin degludec (32.12%). Gastrointestinal side effects were common but diminished with continued use.
Eli Lilly's tirzepatide showed superior performance in glycemic control compared to insulin degludec in a sub-study of the SURPASS-3 clinical trial. The results presented at the EASD meeting indicate participants on tirzepatide 15 mg spent 91.2% of the time within a target glucose range (71-180 mg/dL) over 52 weeks. Additionally, they spent significantly less time in hypoglycemia and exhibited reduced glycemic variability. Overall, tirzepatide's efficacy aligns with its profile as a novel treatment for type 2 diabetes, pending regulatory approvals.
Eli Lilly and Company (NYSE: LLY) has partnered with Susan G. Komen to tackle breast cancer health disparities among Black women in the U.S. This multiyear initiative aims to expand resources and support, providing culturally competent patient navigators, psychosocial support, and educational resources. The program will initially focus on Chicago, St. Louis, and Indianapolis, addressing barriers to early diagnosis and treatment. Black women are 40% more likely to succumb to breast cancer than their white counterparts due to systemic inequities. The collaboration highlights a commitment to health equity in breast cancer care.