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Announcement of listing on the NHI drug price standard and marketing of bag product of Reclast® for i.v. infusion 5 mg

December 9, 2022
Asahi Kasei Pharma Corp.

Asahi Kasei Pharma announces that bag product of Reclast® for intravenous (i.v.) infusion 5 mg (generic name: zoledronic acid hydrate, marketed as: “Reclast®”) for the treatment of osteoporosis has been listed on Japan's National Health Insurance (NHI) drug price standard today. The market launch of the product is scheduled for December 16, 2022.

Asahi Kasei Pharma obtained rights to develop and market the bisphosphonate Reclast® in Japan, and began selling it in November 2016 as an osteoporosis drug capable of a year-long treatment with once-a-year intravenous administration. While Asahi Kasei Pharma has provided Reclast® as a bottle product containing 5.0 mg zoledronic acid hydrate in a 100 mL bottle, it developed a domestically manufactured bag product suited to the Japanese clinical setting, and obtained an additional approval for manufacture and sale of Reclast® as a bag product in August 2022.

Compared with the conventional bottle product, the bag product is expected to offer greater convenience in use at medical institutions by allowing easy disposal of the used container and eliminating the need for an air needle. By leveraging its long experience in the area of osteoporosis therapy, Asahi Kasei Pharma will provide the highly convenient bag product that is desired in the Japanese clinical setting.

Asahi Kasei Pharma aims to realize a society where “no one should have to give up doing what they love due to illness” in accordance with its mission “to sincerely care for each individual life and solve their unmet medical needs with a wealth of ideas and solid science.”

 

About Reclast® bag product

Product name
Reclast® for i.v. infusion 5 mg
Generic name
Zoledronic acid hydrate
Indication
Osteoporosis
Dosage and administration
The usual adult dosage is 5 mg administered by intravenous infusion over not less than 15 minutes, once per year.
Manufacture and sale
Asahi Kasei Pharma Corp.
Approval
August 10, 2022
NHI price listing
December 9, 2022
Launch of sale
December 16, 2022 (scheduled)
NHI price
¥36,045 for a 100 mL bag containing 5 mg Reclast®