1. Home
  2. Press release
Mar 19, 2020 15:15 JST

Source: Eisai

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

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

Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release

Anti-MTBR (microtubule binding region) Tau Antibody Etalanetug Granted FDA Fast Track Designation
September 17 2025 17:20 JST
 
"New Answers to Dementia" Eisai Releases Concept Movie and New Content on Campaign Website for Dementia Month
September 12 2025 12:20 JST
 
Eisai Presents Clinical Study Results of Novel Orexin Receptor Agonist E2086 for Narcolepsy at World Sleep 2025
September 08 2025 16:49 JST
 
Eisai to Present Latest Data on Lemborexant and Novel Orexin Receptor Agonist E2086 at The World Sleep 2025
September 04 2025 09:56 JST
 
Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease Under Fast Track Status
September 03 2025 10:32 JST
 
FDA Approves LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease
September 01 2025 12:44 JST
 
Ministry Of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Anticancer Agent Tazemetostat for Unresectable INI1-Negative Epithelioid Sarcoma
August 29 2025 17:17 JST
 
Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI(R) (lecanemab)
August 25 2025 18:30 JST
 
Eisai Launches In-House Developed Anti-Insomnia Drug DAYVIGO(R) (Lemborexant) in China
August 18 2025 08:11 JST
 
Revenue of LEQEMBI(R) (Preliminary Basis)
July 31 2025 17:27 JST
 
More Press release >>

Latest Press Release


Definitive agreement to implement a joint mine plan between Los Bronces and Andina copper mines
Sep 17, 2025 18:57 JST

Anti-MTBR (microtubule binding region) Tau Antibody Etalanetug Granted FDA Fast Track Designation
Sep 17, 2025 18:20 JST

Honda Announces New Electric Motorcycle "Honda WN7" in Europe
Sep 17, 2025 17:46 JST

EASD 2025 | HighTide Therapeutics Announces Oral Presentation of Phase 3 Data in Patients with Type 2 Diabetes
Sep 17, 2025 09:00 JST

Honda Develops New "Chemical Sorting" Technology to Separate Solid Contaminants from Waste Plastics Derived from End-of-life Automobiles
Sep 16, 2025 15:00 JST

NEC Publishes ESG Initiatives Supporting Sustainable Growth of Companies and Society in "ESG Databook 2025"
Sep 16, 2025 14:00 JST

JSR Corporation/Inpria Corporation and Lam Research Enter Cross Licensing and Collaboration Agreement to Advance Semiconductor Manufacturing
Sep 16, 2025 09:00 JST

Toyota Launches Next-Generation New Mobility e-Palette
Sep 15, 2025 15:33 JST

The University of Osaka D3 Center Commences Operation of New Computing and Data Infrastructure Built by NEC
Sep 12, 2025 15:08 JST

GR Yaris "Aero performance package" Set for Japan Launch
Sep 12, 2025 14:40 JST

Mitsubishi Heavy Industries Achieves Target Performance at Pilot Plant for Bioethanol Membrane Dehydration Systems

Sep 12, 2025 14:19 JST

"New Answers to Dementia" Eisai Releases Concept Movie and New Content on Campaign Website for Dementia Month
Sep 12, 2025 13:20 JST

TANAKA PRECIOUS METAL TECHNOLOGIES Succeeds in Developing High-Performance Palladium Alloy Hydrogen Permeable Membrane Operable in the Low-Temperature Range of 300 degrees C
Sep 12, 2025 11:00 JST

CO2NNEX(R) Digital Platform for Transfer and Management of e-Methane Clean Gas Certificates to Be Utilized in Nagaoka Methanation Demonstration
Sep 11, 2025 20:37 JST

Hitachi accelerates growth with major U.S. investments in advanced manufacturing, electrification and workforce development

Sep 11, 2025 18:35 JST

GlobalLogic and Ericsson Deploy Private 5G Network at Hitachi Rail's State-of the-Art Digital Factory
Sep 11, 2025 17:24 JST

GlobalLogic and Flexware Innovation Announce Major Deployment of LIFT at Hitachi Rail's State-of-the-Art Train Manufacturing Facility
Sep 11, 2025 16:46 JST

JCB Unveils New Brand Message in Vietnam: "Japan Cung Ban"
Sep 11, 2025 13:00 JST

Kawasaki City becomes first dekokatsu subsidy municipality for promoting decarbonization lifestyle promotion project
Sep 11, 2025 10:35 JST

TGR Plans to Reproduce Engine Parts for Corolla Levin / Sprinter Trueno (AE86)
Sep 10, 2025 18:11 JST
 More Latest Release >>