Cardiovascular

U.S. Food And Drug Administration Approves ONGLYZA™ (saxagliptin) For The Treatment Of Type 2 Diabetes Mellitus In Adults

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) approved ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor. ONGLYZA is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus. ONGLYZA once daily can be used in combination with commonly prescribed oral anti-diabetic medications metformin, sulfonylureas or thiazolidinediones (TZD) or as a monotherapy to significantly reduce glycosylated hemoglobin (A1C) levels. ONGLYZA should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). ONGLYZA has not been studied in combination with insulin. Nearly Half of All Adult Patients with Type 2 Diabetes Remain Uncontrolled on Their Current Therapy "The FDA approval of ONGLYZA is an important development for adult patients with type 2 diabetes struggling every day to control their blood sugar levels. Nearly half of adult patients remain uncontrolled on their current treatment regimen and may thus require additional medications," said Elliott Sigal, M.D., Ph.D, executive vice president, chief scientific officer, and president, Research & Development, Bristol-Myers Squibb. "Our ongoing clinical trial program has demonstrated that ONGLYZA showed improved A1C control both in combination and monotherapy settings." "Type 2 diabetes is a daily challenge for adult patients and physicians. With the FDA approval of ONGLYZA, physicians and adult patients with type 2 diabetes have an important new treatment to help improve glucose control," said David Brennan, chief executive officer, AstraZeneca. "ONGLYZA is the product of a major collaboration between AstraZeneca and Bristol-Myers Squibb to further the understanding of how best to treat this challenging disease and help adult patients achieve their treatment goals." ONGLYZA™ (saxagliptin) Clinical Development Program The approval is based on a clinical development program, which included approximately 5,000 individuals, more than 4,000 of whom received ONGLYZA. As part of the development program, ONGLYZA, with diet and exercise, was studied as add-on therapy with other oral anti-diabetic medications, including metformin, the sulfonylurea glyburide and TZDs; in adult patients new to diabetes therapy starting metformin and ONGLYZA together; and as a monotherapy. Throughout the Phase III development program, treatment with ONGLYZA at all doses produced clinically relevant and statistically significant reductions in all three key measures of glucose control studied A1C, fasting plasma glucose (FPG) and post-prandial glucose (PPG) when partnered with other commonly used oral anti-diabetic agents (metformin, sulfonylureas and TZDs), or when used as a monotherapy. ONGLYZA was weight and lipid neutral compared to placebo. ONGLYZA Provides A1C Control Through Effects on Both FPG and PPG Incretin hormones help the body regulate glucose levels in response to meals by influencing the pancreatic secretion of insulin and glucagon. ONGLYZA increases and prolongs the action of incretin hormones by inhibiting the DPP4 enzyme that inactivates incretins usually within minutes. The inhibition of the DPP4 enzyme by ONGLYZA results in an increase in the production of insulin and a decrease in the production of glucagon by the pancreas. These effects are glucose dependent and enhance the body"s natural response to food to reduce blood sugar levels before and after meals. "I continue to see adult patients in my practice who, despite treatment, still have high FPG or high PPG, both of which are key contributors to elevated A1C," said Robert Henry, M.D., Chief, Endocrinology & Metabolism, University of California, San Diego. "The approval of saxagliptin provides a new treatment for adult patients with type 2 diabetes that helps to reduce A1C levels by working across key glucose measures to improve glycemic control." ONGLYZA Complements Metformin to Provide Statistically Significant A1C Reductions ONGLYZA was studied extensively with metformin, the most commonly-prescribed oral anti-diabetic medication. In adult patients inadequately controlled on metformin, the addition of ONGLYZA 2.5 mg (n=192, baseline A1C 8.1 percent) and 5 mg (n=191, baseline A1C 8.1 percent) once daily reduced A1C levels from baseline to Week 24 by -0.6 percent and 0.7 percent respectively for ONGLYZA™ (saxagliptin) vs. +0.1 percent increase for placebo (pComplementary and Statistically Significant A1C Reductions When Added to the Sulfonylurea Glyburide or TZDs ONGLYZA also offered better glucose control for adult patients currently uncontrolled on glyburide. The addition of ONGLYZA 2.5 mg (n=248, baseline A1C 8.4 percent) or 5 mg (n=253, baseline A1C 8.5 percent) to a submaximal total daily dose of glyburide 7.5 mg reduced A1C levels from baseline at week 24 by -0.5 percent and -0.6 percent, respectively for ONGLYZA vs. +0.1 percent increase with an approximate doubling of the total daily dose of the glyburide plus placebo (pONGLYZA Provides Significant A1C Reduction When Used as Monotherapy When studied as a monotherapy, ONGLYZA significantly improved glucose control, with a difference in A1C from baseline of -0.4 percent and -0.5 percent for ONGLYZA 2.5 mg (n=102, baseline A1C 7.9 percent) and 5 mg (n=106, baseline A1C 8.0 percent), respectively, vs. +0.2 percent increase for placebo (pONGLYZA had an Overall Incidence of Side Effects Similar to Placebo In clinical trials, the overall incidence of side effects for ONGLYZA 2.5 mg and 5 mg was similar to placebo (72 percent and 72.2 percent vs. 70.6 percent, respectively). The most common events reported with ONGLYZA 5 mg (т‰Ґ5 percent and more commonly than placebo) were upper respiratory tract infection (7.7 percent vs. 7.6 percent, respectively), urinary tract infection (6.8 percent vs. 6.1 percent, respectively) and headache (6.5 percent vs. 5.9 percent, respectively). In adult patients treated with ONGLYZA 2.5 mg, only headache (6.5 percent) was reported at т‰Ґ5 percent and more commonly than in adult patients treated with placebo. Discontinuation of therapy due to adverse events occurred in 2.2 percent, 3.3 percent, and 1.8 percent of patients receiving ONGLYZA 2.5 mg, ONGLYZA 5 mg, and placebo, respectively. There was a dose-related mean decrease in absolute lymphocyte count observed with ONGLYZA. ONGLYZA™ (saxagliptin) Offers Convenient Once Daily Dosing ONGLYZA offers convenient, once-daily dosing of 2.5 mg or 5 mg that can be taken regardless of meals. ONGLYZA 2.5 mg is recommended for adult patients with moderate or severe renal impairment, or end-stage renal disease requiring hemodialysis (creatinine clearance less т‰¤50 mL/min). ONGLYZA has not been studied in patients undergoing peritoneal dialysis. Assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter. The dose for ONGLYZA should be limited to 2.5 mg when coadministered with strong cytochrome P450 3A4/5 (CYP 3A4/5) inhibitors (e.g., ketoconazole). No dose adjustment is required based on gender, race, weight or hepatic impairment. IMPORTANT INFORMATION ABOUT ONGLYZA Indication and Important Limitations of Use ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ONGLYZA has not been studied in combination with insulin. Important Safety Information -- Use With Medications Known to Cause Hypoglycemia: Insulin secretagogues, such as sulfonylureas, cause hypoglycemia. Therefore, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with ONGLYZA. -- Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA™ (saxagliptin) or any other antidiabetic drug. Most common adverse reactions (regardless of investigator assessment of causality) reported in т‰Ґ5 percent of patients treated with ONGLYZA and more commonly than in patients treated with control were upper respiratory tract infection (7.7 percent, 7.6 percent), headache (7.5 percent, 5.2 percent), nasopharyngitis (6.9 percent, 4.0 percent) and urinary tract infection (6.8 percent, 6.1 percent). When used as add-on combination therapy with a thiazolidinedione, the incidence of peripheral edema for ONGLYZA 2.5 mg, 5 mg, and placebo was 3.1 percent, 8.1 percent and 4.3 percent, respectively. Drug Interactions: Because ketoconazole, a strong CYP 3A4/5 inhibitor, increased saxagliptin exposure, the dose of ONGLYZA should be limited to 2.5 mg when coadministered with a strong CYP 3A4/5 inhibitor (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). Patients with Renal Impairment: The dose of ONGLYZA is 2.5 mg once daily for patients with moderate or severe renal impairment, or with end-stage renal disease requiring hemodialysis (creatinine clearance т‰¤50 mL/min). ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis. Assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter. Pregnant and Nursing Women: There are no adequate and well-controlled studies in pregnant women. ONGLYZA, like other antidiabetic medications, should be used during pregnancy only if clearly needed. It is not known whether saxagliptin is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when ONGLYZA is administered to a nursing woman. Pediatric Patients: Safety

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