(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 ...
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 ...
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 ...
Posology Primary hypercholesterolaemia and mixed dyslipidaemia in adults The recommended dose of Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
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 ...
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 ...
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 ...