Enbrel (Etanercept):Submission of a written request concerning Enbrel
2009-07-01
In Japan, Enbrel is available as a 25 mg dosage strength. While the efficacy of 10 mg and 25 mg does not differ that much, the harmful effects are considered to be bigger in the 25 mg dosage. The risk includes serious infection which may lead to hospitalization or even death. In addition, post-marketing studies, which were under the conditions of governmental approval for this drug, show some weakness in reliability.
On July 1st 2009, we submitted a written request concerning Enbrel (Etanercept) to the Ministry of Health, Labour and Welfare (MHLW), Wyeth and the Japan College of Rheumatology.
< Our Request Outline >
1. Wyeth must promptly complete its double-blind comparative clinical trial on Enbrel (Etanercept) involving an adequate control group and set over a prolonged period (over a year), in order to determine the safety and effects of preventing the progression of joint destruction when taking 10mg or 25mg, as stipulated by section 2, conditions of governmental approval dated January 19th 2005. After completing this trial, Wyeth must immediately analyze and disclose the results. '
2. Until the safety and effectiveness of 25mg of Enbrel is determined following the analysis of the trial results listed in section 1 of our request, the MHLW must approve a dosage of 10mg, and amend the dosage so that the currently approved 25 mg should only be taken as an exception, when the effects of 10mg are insufficient. The Ministry must also publicize this as much as possible.
3. The Japan College of Rheumatology (special investigation committee for the post-marketing surveillance of anti-rheumatic drugs) must reexamine the results of Wyeth's complete survey, and disclose them.
- Related Documents And URL
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- Medwatcher letter on Enbrel（172 KB）
