Supplemental indication for Chugai's Sigmart

Chugai Pharmaceutical, the Japanese subsidiary of Swiss drug major Roche, has announced that acute heart failure (including acute decompensation of chronic heart failure) was supplementally approved in Japan as an indication of Sigmart (nicorandil) 2mg, 12mg and 48mg injection. The drug was already available on the market for the treatment of unstable angina pectoris.

Sigmart, which was synthesized and developed by Chugai and has been available on the market as an anti-unstable anginal drug since 1993, is the only available drug in the world that concomitantly has a nitrate like action and ATP-sensitive potassium channel opening action, the company claims. Clinical studies have been performed in patients with acute heart failure and acute decompensation of chronic heart failure since 1992. These clearly demonstrated that nicorandil improved pre-load and after-load in such patients in a balanced manner, the firm added. Based on these results, Chugai submitted a manufacturing approval partial amendment application on June 6, 2003.