“LIVACT® Granules developed by Ajinomoto Co., Ltd., are therapeutic agents to improve hypoalbuminemia.

Hypoalbuminemia observed in patients with decompensated cirrhosis has been reported to reflect a decrease in protein synthesis capacity in the liver and to be related to the patient's survival.1 Moreover, it is known that the blood concentration of each amino acid in patients with decompensated cirrhosis is in a state of imbalance with a decreased branched-chain amino acid (BCAA) concentration and its degree is inversely correlated with serum albumin levels.2

Based on the knowledge that administration of BCAAs to patients with decompensated cirrhosis improves hypoalbuminemia by correcting blood amino acid imbalance, Ajinomoto Co., Ltd. started the development of this drug containing BCAA as the active ingredient in 1985. Since its usefulness for hypoalbuminemia in patients with decompensated cirrhosis was confirmed, an application for the marketing approval was submitted, and the formulation was approved as "LIVACT® Granules" in January 1996.

After marketing, a "comparative clinical study on survival" (LOTUS Study) was conducted in 646 patients and a drug use-results survey in 3476 patients. In April 2002, an application for re-examination was submitted, and in March 2009, the results of re-examination showed that none of the items (reasons for refusal of approval) in Article 14, Paragraph 2 of the Pharmaceutical Affairs Law are met.

1）Christensen, E., et al.：Hepatology, 4, 430-435, 1984
2) Yasutoshi Muto, et al. Japan Medical Journal, No.3101, 3-9, 1983