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amgen inc (AMGN) Key Developments

Amgen Inc. Plans to Lay Off over 12% of its Workforce

Amgen Inc. announced plans to lay off over 12% of the company's workforce, about 2,900 workers in all.

Amgen Announces Positive Top-Line Results from Phase 3 Yukawa-2 Trial of Evolocumab in Combination with Statins in Japanese Patients with High Cardiovascular Risk and High Cholesterol

Amgen announced that the Phase 3 YUKAWA-2 (StudY of LDL-Cholesterol Reduction Using a Monoclonal PCSK9 Antibody in Japanese Patients With Advanced Cardiovascular Risk) study evaluating evolocumab in combination with statin therapy in Japanese patients with high cardiovascular risk and high cholesterol met its co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. The percent reduction in LDL-C, or 'bad' cholesterol, was clinically meaningful, statistically significant, and consistent with the results observed for the same doses in the Phase 2 YUKAWA trial for evolocumab compared to placebo. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood. The YUKAWA-2 trial evaluated safety, tolerability and efficacy of evolocumab compared to placebo in combination with statin therapy in 404 Japanese patients with high cardiovascular risk and high cholesterol. Patients were randomized to one of eight treatment groups to compare subcutaneous evolocumab (140 mg every two weeks or 420 mg monthly) with subcutaneous placebo (every two weeks or monthly) when added to different daily doses of atorvastatin. Safety was balanced across treatment groups. The adverse events (AEs) that occurred in > 2% of the evolocumab combined group were nasopharyngitis, gastroenteritis and pharyngitis.

Amgen Submits Biologics License Application for Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab to the FDA

Amgen announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for evolocumab seeking approval for the treatment of high cholesterol. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or 'bad' cholesterol, from the blood. The BLA for evolocumab contains data from approximately 6,800 patients, including more than 4,500 patients with high cholesterol in 10 Phase 3 trials. The Phase 3 studies evaluated the safety and efficacy of evolocumab in patients with elevated cholesterol on statins with or without other lipid-lowering therapies; patients who cannot tolerate statins; patients with heterozygous familial hypercholesterolemia (HeFH); and patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder. High cholesterol, particularly elevated LDL-C, is the most common form of dyslipidemia, which is an abnormality of cholesterol and/or fats in the blood. Elevated LDL-C is recognized as a major risk factor for cardiovascular disease. Familial hypercholesterolemia (FH) is an inherited condition caused by genetic mutations which lead to high levels of LDL-C at an early age, and it is estimated that less than 1% of people with FH (heterozygous and homozygous forms) in the U.S. are diagnosed.

FDA Grants Amgen Priority Review Designation for Ivabradine for the Treatment of Chronic Heart Failure

Amgen announced the U.S. Food and Drug Administration (FDA) has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the I(f) current (funny current) in the sinoatrial node, the body's cardiac pacemaker. Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization. Heart failure is a common condition that affects approximately 26 million worldwide, including approximately 5.1 million people in the U.S. The New Drug Application (NDA) is based on global clinical trial data from the Phase 3 SHIFT (Systolic Heart failure treatment with the I(f) inhibitor ivabradine Trial) study, a large, multi-center, randomized, double-blind, placebo-controlled, outcomes trial. The pivotal SHIFT study compared ivabradine to placebo on top of standard-of-care therapies, including beta-blockers, in more than 6,500 patients in sinus rhythm with reduced left ventricular function and heart rate >70 beats per minute (bpm). Priority review designation is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies. A priority review designation will set a goal date for taking action on an application within six months of receipt.

Amgen Appoints Elliott M. Levy as Senior Vice President, Global Development, Effective September 8, 2014

Amgen announced that Elliott M. Levy, M.D., has been named senior vice president, Global Development, effective Sept. 8, 2014. Levy comes to Amgen from Bristol-Myers Squibb (BMS), where he most recently served as senior vice president and head, Specialty Development.

 

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