The FDA has approved the 4-mg maximum dose of Livalo (pitavastatin), manufactured by Kowa Pharmaceuticals America, for the primary treatment of hypercholesterolemia and combined dyslipidemia.
Like other statins, Livalo is intended for patients when diet and exercise fail to lower their cholesterol levels, according to the agency. Statins improve elevated blood cholesterol levels primarily by inhibiting a liver enzyme called HMG Co-A reductase, thus reducing the liver's ability to make cholesterol.
"Elevated or abnormal cholesterol levels are associated with an increased risk for heart disease and stroke," said Eric C. Colman, MD, deputy director of the division of metabolism and endocrinology products at the FDA's Center for Drug Evaluation and Research. "Today's approval offers patients and their healthcare professionals another alternative way to treat high cholesterol."
The FDA said that Livalo was approved on the basis of five clinical trials, comparing its efficacy and safety with that of three currently marketed statins in the U.S. During the trials, the most frequently reported adverse reactions from taking Livalo were muscle pain, back pain, joint pain and constipation.
According to the Montgomery, Ala.-based Kowa, Livalo is expected to launch in the U.S. during the first quarter of 2010, and will be available in three dosages: 1 mg, 2 mg and 4 mg. The company also said it is seeking a co-promotion partner to broaden the reach of Kowa's internal sales force.