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Eli Lilly announced promising results from the Phase 2 SERENITY study of mirikizumab for treating moderate to severe Crohn's disease. The trial reported that nearly 60% of patients achieved significant endoscopic response, while over 45% attained patient-reported outcome remission at 52 weeks. These findings were shared during the UEG Week 2020. The study highlights the potential of mirikizumab as a treatment option, addressing a critical need for new therapies in this challenging condition. Safety profiles were consistent, with common adverse events being manageable.
Eli Lilly and Company (NYSE: LLY) announced promising results from its OVERCOME study, with nearly 80% of participants using CGRP monoclonal antibodies for migraine prevention reporting improvement in their condition. The study surveyed 586 individuals, revealing that 62.6% also used additional recommended preventive medications. These findings, presented at the 18th Migraine Trust International Symposium, highlight the effectiveness of CGRP mAbs and aim to inform healthcare providers on treatment plans. OVERCOME is set to include 100,000 participants globally, solidifying its status as a significant study in migraine treatment.
Eli Lilly and Company (NYSE: LLY) will announce its third-quarter 2020 financial results on October 27, 2020. The company will hold a conference call at 9 a.m. Eastern time to discuss its financial performance, accessible via a live webcast on Lilly's website. A replay will be available post-call. Lilly continues its commitment to healthcare innovation, focusing on delivering life-changing medicines worldwide.
Eli Lilly and Incyte announced new data demonstrating that baricitinib, in combination with remdesivir, significantly reduces recovery time for hospitalized COVID-19 patients. The Adaptive COVID-19 Treatment Trial (ACTT-2) revealed a median recovery time improvement from 8 to 7 days, with a 12.5% relative reduction. Notably, mortality rates dropped 35% through Day 29 among patients receiving the combination therapy, particularly benefiting those requiring supplemental oxygen. Lilly is pursuing Emergency Use Authorization from the FDA for baricitinib's COVID-19 treatment.
Eli Lilly and Company (NYSE: LLY) has partnered with the Bill & Melinda Gates Foundation to improve access to its COVID-19 therapeutic antibodies in low- and middle-income countries. The initiative, part of the COVID-19 Therapeutics Accelerator, aims to facilitate the distribution of these treatments around the world. Manufacturing is set to begin in April 2021, with some volumes available earlier, pending regulatory approval. Collaborators of Lilly have waived their royalties for these therapies in the targeted regions, reinforcing the commitment to equitable healthcare access.
Eli Lilly (NYSE: LLY) provided updates on its SARS-CoV-2 neutralizing antibody programs, sharing interim data from the BLAZE-1 trial. The combination therapy of LY-CoV555 and LY-CoV016 showed significant reductions in viral load and COVID-related hospitalizations. Lilly expects to have up to 1 million doses of LY-CoV555 available in Q4 2020. The company is engaging global regulators for potential Emergency Use Authorization (EUA) for the treatments, with a BLA submission expected as early as Q2 2021. The combination therapy demonstrated a relative risk reduction of 84.5% in hospitalizations.
On October 6, 2020, Eli Lilly announced results from the Phase 3 CENTURION study, indicating that adults taking REYVOW® (lasmiditan) for migraine experienced significantly higher odds of achieving pain freedom at 2 hours compared to placebo. The 200 mg dose showed 7.2 times greater odds, translating to a 20% therapeutic gain, while the 100 mg dose had 3.8 times greater odds with a 10% gain. The trial involved 1,471 participants and demonstrated consistent efficacy across multiple attacks, making REYVOW a promising option for migraine treatment.
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.