Eisai: All-case Surveillance Condition for Approval of "Actonel 17.5 mg tablets" for Treatment of Paget's Disease of Bone Cleared in Japan

Mar 19, 2020 15:15 JST

Source: Eisai

TOKYO, Mar 19, 2020 - (JCN Newswire) - EA Pharma Co., Ltd. and its parent company Eisai Co., Ltd. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has given notification of the results of reexamination to the effect that the "all-case surveillance" specified drug use-results survey condition required for the approval of "Actonel 17.5 mg tablets" (risedronate sodium hydrate) indicated for the treatment of Paget's disease of bone has been lifted.

In July 2008, MHLW approved the indication for treatment of "Paget's disease of bone" for "Actonel 17.5 mg tablets" with the following conditions for approval: "Because of the very limited number of subjects treated in the Japanese clinical trials, the applicant is required to conduct all-case drug use-results survey until data from a certain number of patients are accumulated after market launch, in order to identify the background information of patients treated with the product and collect safety and efficacy data on the product in the early post-marketing period, and thereby take necessary measures to ensure proper use of the product."

Based on the safety data in 307 patients and efficacy data in 276 patients submitted to MHLW as the results of analyses of all-case surveillance, MHLW has concluded that the all-case surveillance was conducted properly and the necessary measures to ensure proper use of the product were being taken sufficiently to lift the condition.

EA Pharma Co., Ltd. and Eisai Co., Ltd. continually strive to promote proper use of the product and provide timely additional information of the product to increase benefits to patients and their families.

Contact:

EA Pharma Co., Ltd. 
Corporate Planning Dept. 
TEL: +81(0)3-6280-9802

Eisai Co., Ltd. 
Public Relations Dept. 
TEL: +81(0)3-3817-5120

Source: Eisai
Sectors: Healthcare & Pharm

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