Chugai News Releases are issued to provide stakeholders with the most up-to-date information related to our company. In some instances, information on products or drug candidates under development may be included, but this is intended for members of the media, shareholders, and investors. The information is not intended for promotional or advertising purposes, or as medical advice, etc.

Dec 09, 2022

  • Pharmaceuticals
  • R&D

Chugai and Towa Launch Edirol Tablet for Osteoporosis Treatment

Chugai Pharmaceutical Co., Ltd.
Towa Pharmaceutical Co., Ltd.

TOKYO, December 9, 2022 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Towa Pharmaceutical Co., Ltd. (TOKYO: 4553) announced that Towa launched Edirol® Tablets 0.5 µg/0.75 µg (generic name: eldecalcitol, hereafter, Edirol Tablet) for an osteoporosis treatment (an active vitamin D3 preparation) upon the listing of the national health insurance (NHI) reimbursement price list today. Edirol Tablet was approved by the Ministry of Health, Labour and Welfare (MHLW) on August 15, 2022.

While Chugai takes responsibilities as a marketing authorization holder, Towa is solely responsible for marketing and providing information on appropriate use of Edirol Tablet. Chugai manufactures Edirol Tablet and supplies to Towa. Chugai continues to market and provide information on Edirol® Capsule 0.5 µg/0.75 µg (hereafter, Edirol Capsule). Towa markets an authorized generic (AG) version of Edirol Capsule.

Edirol is an active vitamin D3 derivative created by Chugai, which can improve calcium and bone metabolism. In Japan, Edirol was launched in April 2011 for the treatment of osteoporosis. In Prevention of Osteoporosis and Clinical Practice Guidelines 2015, Edirol is ranked as grade A as an active vitamin D3 preparation in the efficacy assessment to validate the increase in bone mineral density and decrease in vertebral fracture.

<Edirol® Tablets 0.5 µg/0.75 µg>

Product name: Edirol® Tablets 0.5 µg/0.75 µg
Generic name: eldecalcitol
Indications: Osteoporosis
Dosage and administration: The usual adult dosage is 0.75 µg eldecalcitol administered orally once a day. The dosage should be decreased to 0.5 µg once a day, appropriately depending on symptoms.
Drug price: 0.5µg: JPY 40.30/0.75µg: JPY 56.90
Date of approval: August 15, 2022
Date of NHI reimbursement price listing: December 9, 2022
Date of launch: December 9, 2022
Manufacturer: Chugai Pharmaceutical Co., Ltd.
Distributor: Towa Pharmaceutical Co., Ltd.

[Reference]
Chugai Obtains Regulatory Approval for Osteoporosis Treatment Edirol Tablet
(Press release issued by Chugai and Towa on August 15, 2022)
https://www.chugai-pharm.co.jp/english/news/detail/20220815160000_941.html

About Chugai Pharmaceutical
Chugai Pharmaceutical Co., Ltd., headquartered in Tokyo, is a research-based pharmaceutical company with world-class drug discovery capabilities, including proprietary antibody engineering technologies. Chugai is committed to creating innovative pharmaceutical products that may satisfy unmet medical needs. Chugai is listed on the Prime Market of the Tokyo Stock Exchange. While maintaining autonomy and management independence, Chugai is an important member of the Roche Group. Additional information is available at https://www.chugai-pharm.co.jp/english/.

About Towa
Towa Pharmaceutical is a comprehensive manufacturer of generic drugs, dedicated to R&D, manufacturing, and marketing, striving for the dissemination of generic drugs that can contribute to reducing the economic burden on patients as well as the financial burden on the country. We are also devoted to R&D of value-added products that are easy to drink and tractable to all people involved in pharmaceuticals. With the company’s philosophy “We contribute to people’s health. We are dedicated to people’s genuine smiles,” Towa is also working to newly create health-related businesses. See (https://www.towayakuhin.co.jp/english/) for details.

Trademarks used or mentioned in this release are protected by law.

Contact Information

Chugai Pharmaceutical Co., Ltd.
Corporate Communications Dept.
Media Relations Group
Tel: +81-(0)3-3273-0881

Investor Relations Group
Tel: +81-(0)3-3273-0554

Towa Pharmaceutical Co., Ltd.
Public Relations and Investor Relations Dept.
Tel: +81-(0)6-6900-9102
Fax: +81-(0)6-7177-4960
E-mail: kouhou@towayakuhin.co.jp

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