Company Overview of Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc. provides human prescription medicines. It offers pharmaceutical products for the treatment of lung health, cardiovascular diseases, men's prostate health, and anti-viral therapy. The company’s products include angiotensin II receptor blocker Micardis tablets for the reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients who are unable to take angiotensin-converting enzyme inhibitors; and COMBIVENT RESPIMAT (ipratropium bromide and albuterol), an inhaler for patients with chronic obstructive pulmonary disease. Its products also comprise Flibanserin, a compound for the treatment of hypoactive sexual des...
900 Ridgebury Road
P.O. Box 368
Ridgefield, CT 06877-0368
Founded in 1971
Key Executives for Boehringer Ingelheim Pharmaceuticals, Inc.
Director of Office of Diversity and Inclusion
Manager of Communications and Public Relations
Compensation as of Fiscal Year 2014.
Boehringer Ingelheim Pharmaceuticals, Inc. Key Developments
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company Announces FDA Approvel for Glyxambi
Feb 2 15
The U.S. Food and Drug Administration (FDA) has approved Glyxambi® (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company, to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments. GLYXAMBI is the diabetes treatment in the U.S. to combine the dual mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in a once-daily tablet taken in the morning. GLYXAMBI combines 10 mg or 25 mg of empagliflozin with 5 mg of linagliptin. SGLT2 inhibitors remove glucose through the urine by blocking blood glucose re-absorption in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose. The FDA approval was based on a phase III clinical trial that evaluated the efficacy and safety of GLYXAMBI (10/5 mg and 25/5 mg) compared with the individual components of empagliflozin (10 mg or 25 mg) or linagliptin (5 mg) in adults with T2D who were also taking high-dose metformin (mean dose 1889 mg daily). The study, which randomized 686 adults with T2D and hemoglobin A1C (a measure of average blood glucose over the past two to three months) between 7.0% and 10.5%, examined the change from baseline in A1C at 24 weeks. In the study, as an add-on to metformin, GLYXAMBI showed statistically significant reductions in A1C compared with empagliflozin and linagliptin alone at 24 weeks. Starting from a mean baseline of approximately 8.0%, adults in this trial achieved a mean A1C of 6.9 and 6.7% with GLYXAMBI 10/5 mg and 25/5 mg, respectively, compared with a mean A1C of 7.3% and 7.4% for empagliflozin 10 mg and 25 mg, respectively, and 7.3% for linagliptin 5 mg. The percentage age of patients achieving an A1C less than 7% with GLYXAMBI 10/5 mg or 25/5 mg was 58% and 62%, respectively, compared with 28%, 33% and 36% for empagliflozin 10 mg, empagliflozin 25 mg and linagliptin 5 mg, respectively. Although not approved for lowering weight, GLYXAMBI provided significant weight loss at 24 weeks compared with linagliptin alone.GLYXAMBI 10/5 mg: average body weight reduction of 3.1% from an average baseline of 191 lbs; GLYXAMBI 25/5 mg: average body weight reduction of 3.4% from an average baseline of 187 lbs; Linagliptin 5 mg: average body weight reduction of 0.7% from an average baseline of 187 lbs. Through 52 weeks, the overall incidence of hypoglycemia with GLYXAMBI was 2.2% and 3.6% for GLYXAMBI 10/5 mg and 25/5 mg, respectively, and there were no cases of severe hypoglycemia reported in the trial. A lower dose of an insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia when used in combination with GLYXAMBI. Through 52 weeks, the safety profile of GLYXAMBI was demonstrated in a pooled analysis, and the most common adverse reactions were: Urinary tract infection (UTI): 12.5% and 11.4% for GLYXAMBI 10/5 mg and 25/5 mg, respectively; through 52 weeks, no patient discontinued GLYXAMBI due to UTIs. Nasopharyngitis: 5.9% and 6.6% for GLYXAMBI 10/5 mg and 25/5 mg, respectively· Upper respiratory tract infection: 7.0% for GLYXAMBI 10/5 mg and 25/5 mg.
Boehringer Ingelheim Pharmaceuticals and Eli Lilly Announce Favorable Data from Type 2 Diabetes Analysis
Nov 25 14
Boehringer Ingelheim Pharmaceuticals, Inc., or BIPI, and Eli Lilly and Company have announced favorable data from a new retrospective analysis, which showed that Empagliflozin tablets reduced hemoglobin A1C, body weight and several markers of abdominal fat in adults with type 2 diabetes, or T2D. The FDA approved empagliflozin, marketed as Jardiance, in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with T2D. JARDIANCE is not recommended for people with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). JARDIANCE is not approved to reduce body weight or body fat. Patients should not take JARDIANCE if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in JARDIANCE. The study presented at AHA included analyses of two sets of adults with T2D treated with either empagliflozin or placebo. The first group consisted of 823 adults with high blood pressure who were treated for 12 weeks, while the second examined a pool of 2,476 adults from four different trials who were treated for 24 weeks. These randomized studies compared empagliflozin with placebo as an add-on to existing therapy, including metformin, metformin plus sulfonylurea, or pioglitazone with or without metformin. In both groups, treatment with empagliflozin significantly reduced A1C, body weight and several markers of abdominal fat compared with placebo. Changes in estimated total body fat did not reach statistical significance. In the 12-week study of 823 adults with T2D, compared with placebo, for those treated with empagliflozin: A1C was significantly reduced from a baseline of 7.90% by 0.64% with empagliflozin; Body weight was significantly reduced, from a baseline of 95 kg, by 1.7 kg with empagliflozin; and Total body fat percentage, estimated through an equation based on weight and waist circumference, was not significantly reduced, from a baseline of 35%, by 0.2%.
Boehringer Ingelheim Pharmaceuticals, Inc. Announces Phase I Study
Nov 18 14
Boehringer Ingelheim Pharmaceuticals, Inc. announced phase I study sub-analyses showing that its investigational antidote idarucizumab reverses the effects of dabigatran, the active ingredient in Pradaxa(R) (dabigatran etexilate mesylate), on fibrin formation in healthy volunteers. The results showed idarucizumab, a humanized antibody fragment (Fab), restores wound-site formation of fibrin, the main component of a blood clot. The findings were presented during the American Heart Association's Scientific Sessions 2014. In this sub-study of 35 healthy volunteers, fibrin formation was assessed after a small scratch, similar to a paper cut, was made. Measurements were conducted at baseline, after administration of PRADAXA, and after subsequent administration of idarucizumab or placebo. The results showed that dabigatran almost completely inhibited the production of fibrinopeptide A (FPA), the marker of fibrin formation at the wound site, and that idarucizumab restored FPA production: At baseline, before the volunteers took PRADAXA, the average level of FPA was 3,981 ng/mL. On day three, 2.5 hours after the volunteers took PRADAXA, the average level of FPA was 208 ng/mL, an approximate 95% decrease compared to baseline. On day four, 2.5 hours after the volunteers took PRADAXA and 30 minutes after they were infused with 1 g, 2 g or 4 g of idarucizumab, FPA levels were 24%, 45% and 95%, respectively, of the average baseline level. The restored fibrin production at the wound site after idarucizumab dosing with 2 g or 4 g also correlated with reversal of the dabigatran-anticoagulation activity in circulating blood.
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