Livalo pitavastatin regulatory update

Kowa said the U.K.'s MHRA issued a “positive outcome” on an MAA for pitavastatin to reduce elevated total cholesterol and LDL-C in patients with primary hypercholesterolemia and combined dyslipidemia. The application was submitted under the EU's decentralized procedure, with the U.K. acting as the reference member state. The product is expected to be launched next year. Kowa and Nissan Chemical Industries Ltd. (Tokyo, Japan) co-developed the HMG-CoA reductase inhibitor. ...