Lilly Eli & Co - LLY STOCK NEWS

On September 11, 2020, Health Canada approved Trulicity (dulaglutide) for reducing the risk of non-fatal stroke in adults with type 2 diabetes and cardiovascular risk factors. This makes Trulicity the first GLP-1 receptor agonist with such a cardiovascular indication. The approval is based on the REWIND trial, which demonstrated a significant risk reduction in major adverse cardiovascular events. Dr. Hertzel Gerstein highlighted the importance of this new indication in diabetes care, while Dr. Doron Sagman noted it as a milestone in diabetes and cardiovascular management.

Eli Lilly and Company (NYSE: LLY) announced that Verzenio® (abemaciclib) combined with standard adjuvant endocrine therapy reduced breast cancer recurrence risk by 25% in patients with high-risk HR+, HER2- early breast cancer. The study showed 92.2% invasive disease-free survival in the Verzenio arm compared to 88.7% in the control arm after two years. Additionally, it resulted in a 28% decrease in the risk of metastatic disease. The trial involved over 5,600 participants across 38 countries, with results set for regulatory submission by the end of 2020.

Eli Lilly and Incyte announced that the European Medicines Agency's CHMP has issued a positive opinion for baricitinib (OLUMIANT®) to treat moderate to severe atopic dermatitis (AD) in adults. This marks a significant step towards regulatory approval in Europe, potentially making it the first JAK inhibitor approved for AD. The opinion is based on the Phase 3 BREEZE-AD clinical trials which demonstrated efficacy and safety. A final decision from the European Commission is expected within two months, highlighting the urgency for more treatment options for patients suffering from AD.

Eli Lilly and Incyte announced that their clinical trial ACTT-2 met its primary endpoint, demonstrating a reduction in recovery time for COVID-19 patients treated with baricitinib in combination with remdesivir. The median recovery time was reduced by approximately one day, showing statistical significance. Lilly plans to seek emergency use authorization from regulatory bodies for baricitinib. Ongoing analyses will explore further clinical outcomes, and Lilly is committed to maintaining supply for RA patients while evaluating additional studies on baricitinib's efficacy in COVID-19 treatment.

Eli Lilly announced promising results from the interim analysis of the BLAZE-1 clinical trial for LY-CoV555, a monoclonal antibody targeting COVID-19. The trial revealed a significant 72% decrease in hospitalization rates for patients treated with LY-CoV555 compared to placebo. The primary endpoint of viral load reduction was achieved at a dose of 2800 mg. Additionally, the treatment was well tolerated, with no serious adverse events reported. Ongoing studies will further assess its effectiveness in high-risk populations.

Eli Lilly announced interim results from the BLAZE-1 clinical trial, indicating that its neutralizing antibody, LY-CoV555, significantly reduced COVID-19 related hospitalizations. Patients receiving LY-CoV555 had a 72% lower risk of hospitalization compared to placebo. The primary endpoint of viral load reduction was met at the 2800 mg dosage. The treatment was well-tolerated with no serious adverse events. Ongoing studies will further evaluate LY-CoV555's efficacy and safety in higher-risk populations.

Eli Lilly has announced a new open innovation challenge aimed at enhancing care for individuals with atopic dermatitis. The challenge invites submissions for digital health solutions that improve quality of life for patients dealing with this chronic skin condition. Entries will be accepted until October 21, 2020, with five finalists selected by November 20, 2020. The winning submission will receive a $50,000 award and a potential collaboration opportunity with Lilly. This initiative aligns with Lilly's commitment to leveraging technology for better health outcomes.

The FDA has granted Fast Track designation to Jardiance (empagliflozin) for preventing hospitalization and mortality in patients post-heart attack. Approximately 1.5 million heart attacks annually contribute significantly to heart failure risks. The EMPACT-MI trial aims to evaluate Jardiance's effectiveness in improving survival rates. Jardiance is already approved for lowering blood sugar in type 2 diabetes patients and reducing cardiovascular death risk. Results from the EMPACT-MI trial are anticipated in 2023, marking a critical advance in patient care.

Eli Lilly and Incyte announced promising results from the Adaptive COVID-19 Treatment Trial (ACTT-2), which involved over 1,000 hospitalized patients. The trial assessed the efficacy of baricitinib combined with remdesivir, showing a significant reduction of approximately one day in median recovery time compared to remdesivir alone. This finding is statistically significant and meets the primary endpoint of the study. Lilly intends to seek emergency use authorization for the 4-mg dose of baricitinib for COVID-19 treatment, while also continuing trials to understand its full potential.