THOUSAND OAKS, Calif., Amgen today announced the submission of an application to the U.S. Food and Drug Administration (FDA) seeking approval of a single-dosing option for the monthly administration ...
Eligible patients with high cholesterol (LDL-C ≥70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL) and clinically evident atherosclerotic cardiovascular disease at more than ...
(Reuters) - Amgen Inc said on Friday it had asked the U.S. Food and Drug Administration to approve a monthly single-dosing option for its recently approved cholesterol drug, Repatha. The FDA approved ...
--Amgen today announced positive data from the HAUSER-RCT Phase 3 b study evaluating the safety and efficacy of Repatha ® in pediatric patients, 10-17 years of age, with heterozygous familial ...
THOUSAND OAKS, Calif., March 14, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new detailed data from the Phase 3 YUKAWA-2 study evaluating Repatha™ (evolocumab), a novel investigational ...
The recommended dose for adults with primary disease is either 140 mg every two weeks or 420 mg (the contents of three pre-filled syringes) once a month; both doses are clinically equivalent. For ...
The FINANCIAL — Amgen on April 3 announced new detailed data from the Phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) trial evaluating Repatha ...
Repatha (140 mg) or placebo will be self-administered subcutaneously every two weeks for a minimum of four years. Follow-up of all randomized patients is planned to continue for a minimum of four ...
Approximately 27,500 Patients are Now Fully Enrolled in FOURIER Trial Designed to Evaluate if Repatha in Combination With Statin Therapy Reduces the Risk of Cardiovascular Events. Results From ...
WASHINGTON (Reuters) - Amgen Inc's experimental drug Repatha lowered cholesterol in clinical trials and did not cause a marked disparity in deaths or serious adverse events but showed potential safety ...