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An FDA advisory panel on Tuesday voted 17 to 2 in favor of an expanded indication for the GLP-1 receptor agonist liraglutide, supporting language in the prescribing information that the drug can reduce cardiovascular risk in patients with type 2 diabetes.The decision follows an analysis of primary and secondary endpoints in the LEADER trial, a randomized, double blind, placebo-controlled study conducted at 410 sites in 32 countries. The trial showed that, over a mean 3.8 years, liraglutide (Victoza, Novo Nordisk) reduced the risk for 3-point major adverse cardiac events by 13%, for all-cause death by 15% and for CV death by 22% vs. placebo, while reducing HbA1c and body weight. The FDA requires that all diabetes drugs undergo testing for CV outcomes.NEXT ARTICLE
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...