The FDA has approved Livalo, a statin developed by Kowa Research Institute (KRI) and Kowa Pharmaceuticals America, Inc. (KPA). According to a KPA statement, Livalo is a fully synthetic and highly potent statin engineered in Japan, with a unique cyclopropyl group on the base structure that “contributes to a more effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol production, and potentially affords greater low-density lipoprotein cholesterol (LDL-C) clearance and reduction of plasma cholesterol.”

“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, chief executive officer 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.”

Kowa plans to launch Livalo in the U.S. during 1Q10, and is seeking a co-promotion partner.

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