Application to extend duration of treatment for Teribone™ osteoporosis drug

July 22, 2016
Asahi Kasei Pharma Corp.

Asahi Kasei Pharma has today filed an application with Japan’s Ministry of Health, Labor and Welfare (MHLW) to extend the approved duration of treatment for the osteoporosis drug Teribone™ 56.5 µg subcutaneous injection (generic name: teriparatide acetate).

Sold in Japan since November 2011 with treatment approved for a duration of up to 72 weeks, Teribone™ is a human parathyroid hormone preparation that facilitates bone formation. Asahi Kasei Pharma performed a 24-month clinical study to confirm the safety and efficacy of extending the maximum treatment period, and is applying to the MHLW 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

Osteoporosis with high risk of fracture
The active ingredient is teriparatide, which is peptide fragment 1–34 of the N-terminal region of human parathyroid hormone. Administered in a single 56.5 μg subcutaneous injection 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.