Amgen Inc., an independent biotechnology company, discovers, develops, manufactures, and delivers human therapeutics. Products/Pipeline Cardiovascular Corlanor (ivabradine) In 2015, the company announced that the U.S. Food and Drug Administration (FDA) granted approval of Corlanor to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction =35 percent, who are in sinus rhythm with resting heart rate =70 beats per minute and either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use. Repatha (evolocumab) In 2015, the company announced that the European Commission (EC) granted marketing authorization for Repatha for the treatment of high cholesterol, as an adjunct to diet: Repatha is approved in the European Union (EU) in combination with other lipid-lowering agents in patients with homozygous familial hypercholesterolemia (age 12 and over). In 2015, the company announced that the FDA granted approval of Repatha as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia, who require additional lowering of LDL-C. In 2015, the company announced that it submitted an application to the FDA for a single-dosing option for the monthly administration of Repatha. In January 2016, the company, together with its joint venture partner Astellas Pharma, Inc., announced that the Japanese Ministry of Health, Labour and Welfare approved Repatha for the treatment of patients with familial hypercholesterolemia or hypercholesterolemia who have high risk of cardiovascular events and do not adequately respond to HMG-CoA reductase inhibitors (statins). In February 2016, the company announced that the phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) trial evaluating Repatha in patients with high cholesterol who cannot tolerate statins, met its co-primary endpoints. Nephrology Aranesp (darbepoetin alfa) In February 2016, the company announced that the randomized, double-blind, placebo-controlled phase 3 ARCADE trial met its primary endpoint of reducing the incidence of red blood cell transfusions in anemic patients with low and intermediate-1 risk myelodysplastic syndrome (MDS). Parsabiv (etelcalcetide) In 2015, the company announced that it submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Parsabiv, an intravenous calcimimetic agent, for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. In 2015, the company announced that the FDA accepted for review its New Drug Application (NDA) for Parsabiv for the treatment of SHPT in patients with CKD on hemodialysis. Neuroscience AMG 334 In 2015, the company announced that it initiated phase 3 studies in episodic migraine. AMG 334 is being jointly developed with Novartis AG (Novartis). Oncology BLINCYTO (blinatumomab) In 2015, the company announced that the EC granted conditional marketing authorization for BLINCYTO for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). In February 2016, the company announced that the phase 3 TOWER study evaluating the efficacy of BLINCYTO versus standard of care in adult patients with Ph- relapsed or refractory B-cell precursor ALL, met its primary endpoint of improved overall survival (OS) based on the results of a prespecified interim analysis. IMLYGIC (talimogene laherparepvec) In 2015, the company announced that the FDA granted approval of IMLYGIC for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
amgen inc (AMG:XETRA)
One Amgen Center Drive
Thousand Oaks, CA 91320
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