LIVALO®: FDA Says Yes to New Drug to Lower Cholesterol

In an immediate Press Release on August 3, 2009, Kowa Research Institute (KRI) and Kowa Pharmaceutical America, Inc. (KPA) has announced that the FDA has approved the new drug, Livalo® for Primary Hypercholesterolemia and Combined Dyslipidemia. The generic brand is also known as pitavastatin. Livalo® will help improve blood cholesterol levels in a person who has elevated or abnormal blood cholesterol levels. Livalo® is another statin, which is also intended for patients who have tried to diet and exercise to lower their cholesterol levels without success according the Food and Drug Administration.

Livalo® like other statins improve elevated blood cholesterol levels by inhibiting a liver enzyme called HMG Co-A reductase, which reduces the liver's ability to make cholesterol. The FDA approved Livalo® on the basis of five clinical trials based on its efficacy and safety compared to other statins currently on the market.

KOWA said that Livalo® would help continue to fill current needs that are unmet 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 to lower blood cholesterol levels.

Livalo® is completely synthetic and highly potent statin that was engineered in Japan. In pivotal Phases III trials, Livalo® effectively reduced LDL-C and improved other parameters of lipid metabolism is special patient populations, which include the elderly and patients at higher cardiovascular risk. The overall safety and tolerability of Livalo® are consistent with other commonly prescribed statins.

KOWA is expected to launch Livalo® in the United States during the first quarter of 2010 and Livalo® will be available in 1mg, 2mg and 4mg dosages. Livalo® has been successfully used in Japan, South Korea, Thailand, and China and has accumulated millions of patient-years of exposure. FDA has noted that the some adverse reactions from the drug were muscle pain, back pain, joint pain, and constipation.

A little about Kowa Company, Ltd and Kowa Pharmaceuticals America, Inc.

Kowa Company, Ltd. is a privately held multinational company, which its headquarters are located in Nagoya, Japan. They were established in 1894 and are very active in various manufacturing and trading activities in the fields of pharmaceutical, life science, information technology, textiles, machinery and many other consumer products. Kowa's pharmaceutical division mainly focuses on cardiovascular therapeutics. During their fiscal year of 2008, sales of the company's flagship product, Livalo®, generic name, pitavastatin totaled $340 million in Japan.

Kowa Pharmaceuticals America, Inc. is a specialty pharmaceutical company that mainly focuses on the area of cardiology. The company began in 2001 as ProEthic Pharmaceuticals, Inc. Then in September of 2008, Kowa Company, Ltd acquired a majority stake in the company.