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Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL
Published
Product name
Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL
Active ingredient
Teriparatide acetate
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL (teriparatide acetate) was approved for the following therapeutic use:
Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL (teriparatide acetate) is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures.
Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL (teriparatide acetate) is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.
How this medicine works
Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption. The biological actions of PTH and teriparatide are mediated through binding to specific PTH cell surface receptors. Teriparatide is the synthetic active fragment (1-34) of endogenous human PTH. The proposed teriparatide product is not manufactured using recombinant DNA technology. Teriparatide binds to these receptors with similar affinity as PTH, and has the same actions in bone and kidney as PTH. Like endogenous PTH, teriparatide is not expected to accumulate in bone or other tissues.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology) and risk management plan information submitted by the sponsor. The benefit-risk profile of Teriparatide Lupin, Teriparatide GH and Teriparatide LAPL was considered favourable for the therapeutic use approved.
Sponsor