Eisai Submits sNDA for CLEACTOR for Acute Pulmonary Embolism
Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) submitted on May 26 a supplemental New Drug Application (sNDA) for CLEACTOR (generic name: monteplase (r DNA origin)) for treatment of acute pulmonary embolism to the Ministry of Health, Labour and Welfare in Japan.
CLEACTOR was classified as an orphan drug (a medicine for a rare disease) in March 1998. CLEACTOR is expected as the first t-PA (tissue-type plasminogen activator) drug for the indication of acute pulmonary embolism treatment.
CLEACTOR, the second generation t-PA drug, was independently developed by Eisai utilizing recombinant DNA techniques. The administration of CLEACTOR, when given as a bolus injection, is achieved in about two minutes with an elimination of half-life in blood plasma of greater than 20 minutes. CLEACTOR, was launched with the indication of lysis of coronary thrombus caused by acute myocardial infarction (within 6 hours after onset of symptoms) in June 1998. The company reported sales of about 900 million yen for CLEACTOR for the fiscal year 2002.