FDA Approves LIVALO(R) for Primary Hypercholesterolemia and Combined Dy...( ...),Health

MONTGOMERY, Ala. and MORRISVILLE, N.C., Aug. 3 /PRNewswire/ -- Kowa Research Institute (KRI) based in Morrisville, NC and Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. Food and Drug Administration (FDA) has approved LIVALO(R) (pitavastatin), a potent HMG-CoA reductase inhibitor (statin), for the primary treatment of hypercholesterolemia and combined dyslipidemia.

"The approval of LIVALO is a testament to the commitment and skill of Kowa's clinical development and regulatory groups in successfully bringing a new therapeutic option to a large, competitive market for cardiometabolic disorders," said Ben Stakely, CEO and President, KPA. "KPA is very pleased with the approval of LIVALO and is excited about the opportunity to introduce this new therapeutic option to physicians and patients."

"LIVALO has a robust safety, efficacy and tolerability profile and offers an attractive alternative for patients with primary hypercholesterolemia or combined dyslipidemia," said Antonio M. Gotto Jr., M.D., D.Phil, the Stephen and Suzanne Weiss Dean of Weill Medical College of Cornell University, New York. "LIVALO has very positive attributes that will help continue to fill current unmet needs in the statin market for clinically complex patient populations, such as the elderly, patients with diabetes or patients who take multiple medications for co-morbid conditions."

About LIVALO

LIVALO is a fully synthetic and highly potent statin engineered in Japan. LIVALO differs from other, currently available statins in the U.S. in that it has a unique cyclopropyl group on the base structure. This cyclopropyl group contributes to a more effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol production, and potential
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