Application for approval to manufacture and sell Teribone™ autoinjector
Asahi Kasei Pharma Corp.
Asahi Kasei Pharma today filed an application for approval to manufacture and sell a new formulation of teriparatide acetate tentatively 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 injection* which has been manufactured and sold in Japan since November 2011. As applied for approval, dosage and administration of the new formulation of Teribone™ is “for adults, ordinarily administered in a single 28.2 µg injection twice a week.”
A Phase III bone mass study in Japan for osteoporosis with high risk of fracture (MN-10-T-306 Study) confirmed that Teribone™ 28.2 µg subcutaneous autoinjector was not inferior to the current formulation. Furthermore, as the dose is half that of the current formulation, incidence of side effects such as nausea and vomiting is expected to be reduced.
Asahi Kasei Pharma believes that it can make a significant contribution to the treatment of osteoporosis by providing a new therapeutic option with the new formulation.