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

Eisai to Launch "Pariet S," the First Proton Pump Inhibitor RX-to-OTC in Japan
June 02 2025 16:46 JST
 
New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO (Lemborexant) in China
May 28 2025 16:45 JST
 
Eisai Demonstrates Commitment to Oncology Innovation at ASCO 2025
May 21 2025 14:00 JST
 
Eisai Satisfies All-Case Surveillance Requirement for Anticancer Agent Remitoro
May 16 2025 16:21 JST
 
Eisai Representative Corporate Officer and CEO Haruo Naito Awarded the Order of the Rising Sun, Gold and Silver Star
April 30 2025 13:17 JST
 
Leqembi (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer's Disease to be Authorized in the European Union
April 18 2025 15:52 JST
 
Eisai to Divest Rights for Pariet in China to Peak Pharma
April 01 2025 12:15 JST
 
World's First Early Alzheimer's Disease Treatment Developed in Japan LEQEMBI Receives Prime Minister's Award at the 12th Technology Management and Innovation Awards
March 25 2025 16:28 JST
 
Eisai Selected as a Nadeshiko Brand 2025 as a Listed Company Excelling in Promotion of Women in the Workplace
March 25 2025 11:21 JST
 
Eisai Recognized as "2025 Kenko Investment for Health" for the First Time and Certified as "Outstanding Organization Of Kenko Investment for Health Program (White 500)" for the Sixth Time
March 10 2025 19:24 JST
 
More Press release >>

Latest Press Release


JCB and Mandai Wildlife Group Deepen Partnership with exclusive discounts for JCB cardmembers
Jul 01, 2025 16:00 JST

Fujitsu provides Japan's first AI-powered cloud-based library search service
Jul 01, 2025 11:30 JST

JCB Brings Apple Pay to Cardmembers in Vietnam
Jul 01, 2025 11:15 JST

First Shipment of LNG from the LNG Canada Project
Jul 01, 2025 11:00 JST

Approval in Principle (AiP) for World's First LCO2 / Methanol Carrier
Jun 30, 2025 20:30 JST

Acropolis Rally Greece: Day 4 Sunday success and second overall for TOYOTA GAZOO Racing's Ogier
Jun 30, 2025 20:15 JST

Mitsubishi Fuso-Hino Merger: 4 Firms Collaborate for the Future of Commercial Vehicles
Jun 30, 2025 20:10 JST

Six Companies Establish BlueRebirth Council to Expand Use of Recycled Materials in New Vehicles
Jun 30, 2025 19:25 JST

Honda Changes Plan to Build New Production Plant for Next-generation Fuel Cell Module in Japan
Jun 30, 2025 19:20 JST

MHI-AC&R Receives Recommendation Award of JARAC's 42nd Excellent Energy Saving Equipment Awards
Jun 30, 2025 19:00 JST

The University of Osaka and Fujitsu Japan launch joint research on AI-powered education support for culturally and linguistically diverse children in Japan
Jun 30, 2025 12:00 JST

JCB has launched contactless subway payment services in Shanghai and Beijing, marking the first such service in mainland China
Jun 30, 2025 12:00 JST

Honda Opens "Honda Software Studio Osaka" as New Software Development Operation
Jun 26, 2025 13:30 JST

Honda Issues "Honda ESG Report 2025"
Jun 26, 2025 13:29 JST

Fujitsu's Uvance Wayfinders consulting empowers customers to evolve business foundations leveraging data and AI
Jun 26, 2025 11:00 JST

MHI Receives Contract for Refurbishment of APM System at Singapore Changi Airport
Jun 25, 2025 14:00 JST

Special Summer Event "Tanabata Festival at Anime Tokyo Station" Feature a Public Recording of a Chat and Dramatic Reading by Voice Actors Miina Tominaga and Wataru Takagi on July 7
Jun 25, 2025 11:00 JST

Technica Zen and BSI Professional Services Japan Launch Customizable Training to Strengthen AI Governance in Japanese Companies
Jun 25, 2025 10:00 JST

Executive Appointments in Connection with the Establishment of NESIC Holdings
Jun 23, 2025 19:22 JST

Hua Medicine Announces at 2025 ADA Scientific Sessions that Dorzagliatin Combined with DPP-4 Inhibitor Shows Promise in Reducing Blood Lipids While Restoring Glucose Homeostasis
Jun 23, 2025 13:05 JST
 More Latest Release >>