Asahi Kasei Pharma receives approval to extend treatment duration for Teribone™ osteoporosis drug

May 18, 2017
Asahi Kasei Pharma Corp.

Asahi Kasei Pharma today obtained approval for an extension of the maximum duration of treatment for the osteoporosis drug Teribone™ 56.5 µg subcutaneous injection (generic name: teriparatide acetate) from 72 weeks to 24 months.

Sold in Japan since November 2011 with treatment approved for a duration of up to 72 weeks, Teribone™ is an osteoporosis drug that facilitates bone formation, and used for the treatment of osteoporosis with high risk of fracture. Asahi Kasei Pharma filed an application on July 22, 2016, to Japan’s Ministry of Health, Labor and Welfare for approval to extend the maximum treatment period to 24 months.

Asahi Kasei Pharma believes that an extension of the maximum duration of treatment for Teribone™ will further enhance the treatment of osteoporosis.

About Teribone™ 56.5 µg subcutaneous injection

Indication
Osteoporosis with high risk of fracture
Dosage and administration
For adults, ordinarily administered in a single 56.5 µg injection once a week for up to 24 months.
Characteristics
The active ingredient is teriparatide, which is peptide fragment 1-34 of the N-terminal region of human parathyroid hormone. Administered once a week, it facilitates bone formation by activating osteoblasts, which inhibits fracture through increased bone strength with both improved bone quality and increased bone mass.