eli lilly & co (LLY) Key Developments
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company Announce U.S. FDA Approves Synjardy (Empagliflozin/Metformin Hydrochloride) Tablets for Adults with Type 2 Diabetes
Aug 27 15
The U.S. Food and Drug Administration (FDA) has approved Synjardy (empagliflozin and metformin hydrochloride) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company, for the treatment of adults with type 2 diabetes (T2D). SYNJARDY is the third product containing empagliflozin to be approved by the FDA, following Jardiance (empagliflozin) and Glyxambi (empagliflozin/linagliptin). SYNJARDY is a combination of empagliflozin and metformin — two medicines with complementary mechanisms of action — to help control blood glucose in people with T2D. Empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Metformin, a commonly prescribed initial treatment for T2D, lowers glucose production by the liver and its absorption in the intestine.
Adocia and Eli Lilly Initiate New Phase 1b Study of Repeated Administration of Ultra-Rapid Biochaperone Lispro in Patients with Type 1 Diabetes
Aug 27 15
Adocia and Eli Lilly and Company announced the initiation of a Phase 1b clinical trial evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly. This formulation uses Adocia’s proprietary technology BioChaperone, which is designed to accelerate insulin absorption. This new study under the Adocia-Lilly partnership aims to compare the effect of BioChaperone Lispro, injected either at mealtime or 15 minutes after the meal, on post-meal glycemic control in type 1 diabetes patients to that of Humalog® (insulin lispro rDNA origin) over the same two-week period. Commercialized fast-acting insulin analogs are usually injected before the meal. An ultra-rapid insulin aims to allow injection at the time of the meal, or even after the start of a meal, with the goal of reducing the magnitude of glycemic excursions. In this crossover, randomized, double-blind study, 36 type 1 diabetes patients will receive multiple daily doses of BioChaperone Lispro and Humalog over two periods of 14 days each. The main objective is to compare post-meal glucose profiles after identical bolus injections of either BioChaperone Lispro or Humalog relative to a solid meal stimulus. Additionally the study will document the safety and efficacy of an ultra-rapid insulin absorption profile in an outpatient setting. This study will be sponsored by Adocia, and performed by Profil Neuss in Germany. Additional Phase 1b clinical studies will be conducted this year in order to understand performance for additional diabetic patient needs.
U.S. District Court Rules in Lilly's Favor on Alimta Vitamin Regimen Patent
Aug 25 15
Eli Lilly and Company announced that the U.S. District Court for the Southern District of Indiana has ruled in the company's favor regarding infringement of the vitamin regimen patent for Alimta® (pemetrexed for injection). In the case of Eli Lilly and Company v. Teva Parenteral Medicines, Inc., the court ruled that the vitamin regimen patent would be infringed by the generic challengers' proposed products. The patent provides intellectual property protection for Alimta until May 2022. In March 2014, the court previously upheld the validity of the vitamin regimen patent. The Alimta compound patent remains in force through early 2017.
Boehringer Ingelheim and Eli Lilly and Company Announce Positive Top-Line Results from EMPA-REG OUTCOME
Aug 20 15
Boehringer Ingelheim and Eli Lilly and Company announced positive top-line results from EMPA-REG OUTCOME®. This is a long-term clinical trial investigating cardiovascular (CV) outcomes for Jardiance® (empagliflozin) in more than 7,000 adults with type 2 diabetes (T2D) at high risk for CV events. EMPA-REG OUTCOME met its primary endpoint and demonstrated superiority of JARDIANCE, when added to standard of care, in CV risk reduction. The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal myocardial infarction or non-fatal stroke. JARDIANCE is the only glucose-lowering agent to have demonstrated CV risk reduction in a dedicated cardiovascular outcomes trial. The safety profile of JARDIANCE was consistent with previous studies.
Eli Lilly and Company Announces Humalog® 200 Units/mL KwikPen Now Available in U.S. Pharmacies
Aug 18 15
Eli Lilly and Company announced Humalog® 200 units/mL KwikPen® (insulin lispro 200 units/mL; U-200), the first and only concentrated mealtime insulin analog in the U.S., is now available in pharmacies. Humalog U-200 KwikPen is a prefilled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes. It is intended for people who are already taking mealtime insulin. Humalog U-200 KwikPen holds twice as many units of insulin (600 units vs. 300 units) as the U-100 formulation in the same three-milliliter cartridge volume, offering patients a pen that lasts longer, which facilitates fewer pen changes every month. This may help patients who require higher daily doses of mealtime insulin fit their treatment into their lives. The most common side effect of Humalog is hypoglycemia (low blood sugar) that may be severe and cause unconsciousness, seizures and death. Humalog U-200 KwikPen delivers the same dose in half the volume of U-100 mealtime insulin pens, with no dose conversions required, and can be dialed in one-unit increments to a maximum of 60 units per injection.