Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 6 mcg, 9 mcg, 12 mcg, 15 mcg, 18 mcg, 21 mcg, 24 mcg, 27 mcg, 30 mcg) |
Drug Class | Parathyroid hormone analogs |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of hypoparathyroidism in adults.
Latest News
Summary
- Yorvipath (palopegteriparatide) is indicated for the treatment of hypoparathyroidism in adults.
- This summary is based on the review of one randomized controlled trial(s). [1]
- Composite Primary Efficacy Endpoint: At week 26, 79% (48/61) of participants treated with TransCon PTH achieved normal albumin-adjusted serum calcium levels, independence from conventional therapy, and no increase in study drug, compared to 5% (1/21) in the placebo group (p < 0.0001).
- Health-Related Quality of Life (SF-36) and Hypoparathyroidism-Related Symptoms (HPES): TransCon PTH resulted in significant improvements in the SF-36 Physical Functioning subscale (p = 0.0347) and in all key secondary endpoint HPES domain scores (all p < 0.01), indicating enhanced well-being and reduced hypoparathyroidism-related symptoms.
- Independence from Conventional Therapy: 93% (57/61) of participants on TransCon PTH achieved independence from conventional therapy, with no comparative data provided for the placebo group.
- Adverse Events: 82% (50/61) of participants on TransCon PTH experienced adverse events, with most being mild (46%) or moderate (46%) in severity. In the placebo group, 100% (21/21) experienced adverse events, though severity details were not provided.
- Withdrawals: There were no study drug-related withdrawals in the TransCon PTH group. No comparative data were provided for the placebo group.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
YORVIPATH (palopegteriparatide) Prescribing Information | 2024 | Ascendis Pharma Endocrinology Inc., Princeton, NJ |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Efficacy and safety of parathyroid hormone replacement with TransCon PTH in hypoparathyroidism: 26-week results from the phase 3 PaTHway Trial. | 82Subjects F: 78% M: 22% | 2023 | Journal of Bone and Mineral Research |
Sex Distribution:
F:78%
M:22%
82Subjects
Year:
2023
Source:Journal of Bone and Mineral Research