Approval to manufacture and sell Teribone™ autoinjector

September 20, 2019
Asahi Kasei Pharma Corp.

Asahi Kasei Pharma today obtained approval to manufacture and sell a new autoinjector formulation of teriparatide acetate named Teribone™ 28.2 µg subcutaneous autoinjector in Japan for treatment of osteoporosis with high risk of fracture.

Teribone™ 28.2 µg subcutaneous autoinjector contains the same teriparatide acetate agent as Teribone™ 56.5 µg subcutaneous injection1 which has been manufactured and sold in Japan since November 2011. The approved dosage and administration of the new autoinjector formulation of Teribone™ is “for adults, ordinarily administered in a 28.2 µg subcutaneous injection twice a week, for up to 24 months.”

A Phase III bone mass study in Japan for osteoporosis with high risk of fracture (MN-10-T-306 Study)2 demonstrated that Teribone™ 28.2 µg subcutaneous injection twice a week was not inferior to the current formulation in terms of the primary endpoint of percentage change in spine bone mineral density at final assessment from the baseline, and that there tended to be a lower rate of incidence of side effects such as nausea and vomiting.

The new formulation is a single-use autoinjector and it enables easy administration.

Asahi Kasei Pharma believes that it can make a significant contribution to the treatment of osteoporosis by providing an additional therapeutic option with the new formulation.

  1. 1 Dosage and administration of the present formulations is “for adults, ordinarily administered in a single 56.5 µg subcutaneous injection once a week, for up to 24 months.”
  2. 2 Sugimoto, T. et al. Osteoporos Int (2019). https://doi.org/10.1007/s00198-019-05111-6

About Teribone™ 28.2 µg subcutaneous autoinjector

Product name
Teribone™ 28.2 µg subcutaneous autoinjector
Generic name
Teriparatide acetate
Indication
Osteoporosis with high risk of fracture
Dosage and administration
For adults, ordinarily administered in a single 28.2 µg subcutaneous injection twice a week, for up to 24 months
Teribone™ 28.2 µg subcutaneous autoinjector
Teribone™ 28.2 µg subcutaneous autoinjector