Takeda recalls anti-inflammatory Dasen in Japan due to efficacy

Japan’s largest drugmaker, Takeda Pharmaceutical (TSE: 4502), says it has voluntarily recalled Dasen (serrapeptase) 5mg and 10mg tablets, and 1% granules, its anti-inflammatory enzyme preparations sold in Japan, starting on February 21.

In the double-blind studies that have been conducted to compare Dasen with placebo no statistical significant differences were found. Based on the results of these, the Committee on Reevaluation of the Pharmaceutical Affairs and Food Sanitation Council of the Ministry of Health, Labor and Welfare of Japan held a meeting on January 19, 2011, to consider the drug.

As a result, the Committee pointed out the necessity of conducting additional trials in a manner that reflects current clinical treatment practices, and to prove the efficacy of Dasen. In accordance with the instruction of the MHLW, Takeda has been studying the feasibility of conducting such studies. Takeda believes that the efficacy of Dasen would be confirmed through additional clinical trials with a revised study design, however, it has concluded that it would be difficult to conduct additional studies as requested.