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The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) from Eli Lilly and Boehringer Ingelheim. This sNDA targets reducing cardiovascular death and hospitalization for heart failure in adults, especially those with chronic heart failure with reduced ejection fraction. The sNDA is based on the EMPEROR-Reduced trial results, showing Jardiance reduced the risk of cardiovascular death or hospitalization by 25%. The FDA previously granted Fast Track designation for its use in heart failure treatment. Further results are awaited from the EMPEROR-Preserved trial.
Eli Lilly's investigational antibody, donanemab, demonstrated a 32% reduction in cognitive decline in early symptomatic Alzheimer's patients compared to placebo in the Phase 2 TRAILBLAZER-ALZ study. This study, involving 272 patients, met its primary endpoint in the Integrated Alzheimer's Disease Rating Scale (iADRS). Notable safety observations included 27% incidence of amyloid-related imaging abnormalities (ARIA-E). The study's full results will be submitted for publication, with plans for further discussions with global regulators regarding next steps for donanemab.
Eli Lilly and Company (NYSE: LLY) will participate in the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021. David A. Ricks, the company's CEO, is set to engage in a virtual fireside chat at 8:20 a.m. Eastern time. A live audio webcast will be accessible through the "Webcasts & Presentations" section of Lilly's Investor website. The presentation will be available for replay for about 90 days. Lilly aims to innovate healthcare by discovering medicines that improve lives globally.
Principle LTC's Tower Nursing & Rehabilitation Center has partnered with Eli Lilly to conduct a Phase 3 clinical trial of bamlanivimab and etesevimab. This trial aims to prevent SARS-CoV-2 infections and treat high-risk COVID-19 patients in long-term care facilities. The study's early data shows that bamlanivimab may prevent severe symptoms in early-stage patients, helping to mitigate the impact of COVID-19 on vulnerable populations. Participation is voluntary, and a mobile research unit will provide onsite infusions when COVID-19 criteria are met.
Eli Lilly and Company (NYSE: LLY) announced a new pragmatic study of bamlanivimab (LY-CoV555) targeting high-risk COVID-19 patients in New Mexico. This study aims to evaluate the drug's effectiveness and safety in real-world settings, using mobile research units for easier access. Bamlanivimab recently received Emergency Use Authorization (EUA) from the FDA for treating mild to moderate COVID-19 in high-risk groups. However, the drug is not approved for widespread use and carries potential risks for patients requiring high-flow oxygen or hospitalization.
Eli Lilly and Company (NYSE: LLY) announced its 2021 financial guidance, projecting revenue growth between $26.5 billion and $28.0 billion, with significant contributions from COVID-19 therapies. The company expects earnings per share (EPS) in the range of $7.25 to $7.90 on a reported basis. Lilly anticipates operating margins of approximately 30% and significant investments in R&D, including $6.5 billion to $6.7 billion for 2021. The updated guidance also reflects a 15% increase in dividends. Strong cash flow is projected to support shareholder returns and pipeline expansion.
Eli Lilly and Company (NYSE: LLY) has announced a 15% increase in its quarterly dividend, raising it to $0.85 per share for Q1 2021. This adjustment elevates the annual indicated rate to $3.40 per share. Shareholders of record on February 12, 2021, will receive the dividend on March 10, 2021.
Eli Lilly and Company (NYSE: LLY) announced the opening of patient enrollment for the New IDEAS Study, aimed at investigating the impact of amyloid PET scans on Alzheimer's disease patient management. This study will enroll 7,000 participants, focusing on diversity, with over 50% identifying as Black/African American or Hispanic/Latino. The initiative builds on the original IDEAS Study, which enrolled 18,000 participants. The New IDEAS aims to enhance understanding of amyloid imaging's role in patient care while addressing gaps in clinical trial diversity.
Eli Lilly and Incyte announced publication of peer-reviewed results from the Adaptive COVID-19 Treatment Trial (ACTT-2) in The New England Journal of Medicine. The Phase 3 study demonstrated that baricitinib, combined with remdesivir, shortened recovery times and lowered the risk of progression to ventilation or death in hospitalized COVID-19 patients. This supports the emergency use authorization (EUA) granted by the FDA on Nov. 19. Though not FDA-approved for COVID-19, baricitinib is authorized for use in hospitalized patients requiring supplemental oxygen.
Eli Lilly announced favorable results from the Phase 3 monarchE trial for Verzenio (abemaciclib), showing a 28.7% reduction in breast cancer recurrence risk in patients with hormone receptor-positive, HER2-negative early breast cancer when combined with standard adjuvant endocrine therapy.
The results, presented at the 2020 Virtual San Antonio Breast Cancer Symposium, indicated an improvement in invasive disease-free survival at 92.3% versus 89.3% in control. The data involved over 1,400 patients and showed consistent benefits across subgroups. Lilly plans to submit these findings to regulatory authorities by year-end 2020.