Drug updated on 12/11/2024
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
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Summary
- This summary is based on the review of two randomized controlled trial(s). [1-2]
- Renal Function Improvement: Treatment with TransCon PTH (palopegteriparatide) significantly increased estimated glomerular filtration rate (eGFR) by a mean (standard deviation (SD)) of 9.3 (11.7) mL/min/1.73 m² at week 52 (P < 0.0001), with a larger mean (SD) increase of 11.5 (11.3) mL/min/1.73 m² (P < 0.001) observed in participants with baseline eGFR < 60 mL/min/1.73 m².
- Composite Efficacy Outcomes: At week 26, 79% (48/61) of participants receiving TransCon PTH achieved normal albumin-adjusted serum calcium levels, independence from conventional therapy, and no dose escalation, compared to 5% (1/21) in the placebo group (P < 0.0001).
- Secondary Outcomes: TransCon PTH significantly improved quality of life as measured by the Hypoparathyroidism Patient Experience Scale (HPES) (P < 0.01) and SF-36 Physical Functioning subscale (P = 0.0347). Additionally, 93% (57/61) of treated participants achieved normocalcemia and independence from conventional therapy during the 26-week period. 5. 82% (50/61) of participants treated with TransCon PTH (palopegteriparatide) experienced adverse events, with the majority being mild (46%) or moderate (46%); no study drug-related withdrawals occurred. In the placebo group, 100% (21/21) of participants experienced adverse events, including one case of nephrolithiasis during the blinded treatment phase.
- No cases of nephrolithiasis were reported in the TransCon PTH (palopegteriparatide) group through week 52.
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 |
---|---|---|---|
Palopegteriparatide Treatment Improves Renal Function in Adults with Chronic Hypoparathyroidism: 1-Year Results from the Phase 3 PaTHway Trial | 82Subjects F: 78% M: 22% | 2024 | Advances In Therapy |
Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial | Data not availableSubjects F: null% M: null% | 2023 | Journal Of Bone And Mineral Research : The Official Journal Of The American |
Sex Distribution:
F:78%
M:22%
82Subjects
Year:
2024
Source:Advances In Therapy
Sex Distribution:
Year:
2023
Source:Journal Of Bone And Mineral Research : The Official Journal Of The American