11 January 2013 | News | By BioSpectrum Bureau
Pronova, Takeda launch hyperlipidemia drug Lotriga in Japan
Good news for hyperlipidemia patients - Pronova BioPharma and Takeda launch Lotriga in Japan
Singapore: Pronova BioPharma and Takeda's Lotriga granular capsule 2g is now available for the treatment of hyperlipidemia in Japan. Lotriga, discovered by Pronova, is the omega 3-derived prescription drug containing highly concentrated and purified EPA-E (eicosapentaenoic acid ethyl ester) and DHA-E (docosahexaenoic acid).
It is already on the market in 60 countries including the US and Europe. In 2005, Takeda and Pronova entered into a license and supply agreement in which Takeda was granted an exclusive development and marketing right to this product in Japan. Lotriga will be the first prescription medicine in Japan that contains both EPA-E and DHA-E.
In the phase III clinical trial conducted in Japan upon submission, the efficacy and safety of Lotriga for Japanese patients with hypertriglyceridemia have been evaluated with a EPA. The trial demonstrated that 2g (once daily) of Lotriga was equal, and 4g (2g twice daily) of Lotriga was statistically superior to the EPA, in the percent change of triglycerides from the baseline. Lotriga was safe and well tolerated, with a safety profile comparable to the EPA.
Mr Morten Jurs, CEO, Pronova, remarked that, "We believe Lotriga provides a new treatment option for hyperlipidemia patients in Japan and we are therefore very pleased that Takeda has launched Lotriga in the Japanese market. The launch marks an important milestone in our geographical expansion strategy and will substantially increase our reach to the patients facing cardiovascular risks that can gain benefits from this triglyceride reducing treatment."
Mr Masato Iwasaki, director and senior vice president, pharmaceutical marketing division of Takeda, remarked that, "With the launch of Lotriga, we now have a well-rounded product portfolio in the field of lifestyle diseases such as diabetes, hypertension and hyperlipidemia. As these diseases are often concurrent in same patients, we expect that we can contribute further to their health by providing the treatment regimen in accordance with the individual pathologic conditions."