Phase 3 Studies Show Lilly’s Ultra Rapid Lispro Met Primary Efficacy Endpoint in People with Type 1 and Type 2 Diabetes
Readouts from two phase 3 clinical trials demonstrated that Eli Lilly and Company’s Ultra Rapid Lispro (URLi) met the primary efficacy endpoint of non-inferior A1C reduction from baseline compared to Humalog (insulin lispro) and also demonstrated significantly improved post-meal glucose control in people with type 1 and type 2 diabetes. URLi is Lilly’s novel mealtime insulin formulation that was developed to…
Lilly’s Emgality Significantly Reduces Migraines
Eli Lilly and Company announced results from a post-hoc analysis which demonstrated efficacy of Emgality (galcanezumab-gnlm) in patients with episodic and chronic migraine who had previously failed preventive treatment with Botox (onabotulinumtoxinA). Detailed results from a post-hoc analysis of three Phase 3 studies (Evolve-1, Evolve-2 and Regain) will be presented as a late-breaking presentation on Saturday, June 30 at the…
Empagliflozin Achieves Positive Top-Line Phase III Data Results
Boehringer Ingelheim and Eli Lilly and Company announced that both randomized controlled trials in the EASE Phase III program, investigating the use of empagliflozin in combination with insulin therapy in adults with type 1 diabetes, met their primary endpoint. The primary efficacy endpoint, defined in both trials as placebo-corrected change from baseline in A1C after…
Eli Lilly’s Jardiance Shows Promising Results
Boehringer Ingelheim and Eli Lilly and Company announced findings from two new analyses of the landmark EMPA-REG OUTCOME trial, presented at the 78th American Diabetes Association (ADA) Scientific Sessions. Results include a post-hoc analysis demonstrating consistent effects for Jardiance versus placebo on renal outcomes in patients with established cardiovascular (CV) disease and type 2 diabetes, irrespective of control…
FDA Expands Lilly’s Alimta Label
Eli Lilly received approval for a new indication for Alimta (pemetrexed for injection) in combination with carboplatin and Keytruda (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status. Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival (PFS).…
Lilly Receives First FDA Approval On Taltz Psoriasis Label Update
The U.S. Food and Drug Administration (FDA) has approved a label update for Eli Lilly and Company’s Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area.1 Taltz is the first and only treatment approved by the FDA for moderate-to-severe plaque psoriasis that includes such data in its label.1 Taltz was first approved…
Lilly’s Galcanezumab Meets Primary Endpoint In Phase 3 Study
Eli Lilly’s galcanezumab met its primary endpoint in a Phase 3 study of patients with episodic cluster headache, demonstrating statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period. A statistically significantly greater percentage of patients treated with galcanezumab also achieved…
Lilly Receives Additional FDA Approval for Verzenio as Initial Treatment for Advanced Breast Cancer
Top-Line Results Reported For Lilly’s Taltz In Spinal Inflammatory Arthritis
Lilly announces positive top-line Phase 3 results for Taltz (ixekizumab) in ankylosing spondylitis (radiographic axial spondyloarthritis). Eli Lilly’s Taltz (ixekizumab) met the primary and all key secondary endpoints in COAST-V, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (axSpA). The trial included…
Lilly Announces 2018 Financial Guidance And Enhances Outlook Through 2020
The FDA Accepts Eli Lilly’s BLA For Migraine Drug Review
FDA accepts Biologics License Application (BLA) to review galcanezumab for the prevention of migraine in adults. The U.S. Food and Drug Administration (FDA) has accepted Eli Lilly and Company’s Biologics License Application (BLA) to review galcanezumab for the prevention of migraine in adults. Galcanezumab has been submitted for use as a once-monthly, self-administered injection via auto-injector pen or…
Lilly Announces $72M Investment In Diabetes Manufacturing In Indianapolis
Lilly’s Urothelial Cancer Trial Meets Endpoint, Improves Survival Chance
Lilly Announces Series of Organizational and Leadership Changes
Lilly Announces Program to Provide Insulin at Discounted Prices
Boehringer-Lilly Diabetes Drug Gets FDA Approval
U.S. FDA approves Synjardy XR (empagliflozin/metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. The U.S. Food and Drug Administration (FDA) has approved Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. When used along with diet and exercise, Synjardy XR is indicated to improve blood sugar in adults with…
