The US Food and Drug Administration (FDA) has approved Livalo (pitavastatin), a new drug to lower cholesterol manufactured by Kowa Pharmaceuticals America.
Livalo (pitavastatin) used as a 4mg maximum dose is intended to improve blood cholesterol levels in those with elevated or abnormal blood cholesterol levels, when diet and exercise has failed.
Livalo is a statin that improves elevated blood cholesterol levels primarily by inhibiting a liver enzyme called HMG-CoA reductase, thereby reducing the liver’s ability to make cholesterol.
FDA Centre for Drug Evaluation and Research Division of Metabolism and Endocrinology Products deputy director Eric Colman said that elevated or abnormal cholesterol levels are associated with an increased risk for heart disease and stroke.
“Today’s approval offers patients and their healthcare professionals another alternative way to treat high cholesterol,” Colman said.
Livalo was approved after five successful clinical trials, which compared the drug’s efficacy and safety to that of three currently marketed statins.
The most frequently reported adverse reactions from taking Livalo were muscle pain, back pain, joint pain and constipation.