Palopegteriparatid (1) – Yorvipath®
Chronic hypoparathyroidism, parathyroid hormone (PTH) substitution therapy
Characteristics
| Start date | 01.01.2024 – Marketing authorisation: 17.11.2023 |
|---|---|
| Resolution | 20.06.2024 |
| INN | Palopegteriparatid |
| Brand name | Yorvipath® |
| Pharm. company | Ascendis Pharma Endocrinology GmbH |
| G-BA Procedure ID | D-1010 |
| ATC code | H05AA05 Parathyroid hormones and analogues (H05AA) |
| ICD-10 codes (AIS) | E20.0Idiopathic hypoparathyroidism, E20.8Other hypoparathyroidism, E20.9Parathyroid tetany, E89.2Parathyroprival tetany |
| Alpha-ID codes (AIS) | I14257Hypoparathyroidism, I2212Idiopathic hypoparathyroidism, I71154Acquired absence of the parathyroid gland, I73280Familial hypoparathyroidism |
| Therapeutic area | Metabolic diseases Hypoparathyroidism Orphan |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Yorvipath is a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with chronic hypoparathyroidism for whom parathyroid hormone replacement therapy is an option | Parathyroid hormone |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (PaTHwa) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
- Clinical trials
- In the comparative trial phase, the active ingredient palopegteriparatide was compared with placebo.
Adults with chronic hypoparathyroidism who are eligible for parathyroid hormone replacement therapy
- For adults with chronic hypoparathyroidism who are eligible for parathyroid hormone replacement therapy, the additional benefit of palopegteriparatide compared with the appropriate comparator therapy is not proven.
- The pharmaceutical manufacturer has not submitted any data for the assessment of the additional benefit of palopegteriparatide compared with the appropriate comparator therapy.
- The PaTHway study submitted by the pharmaceutical manufacturer is not suitable for assessing additional benefit due to the lack of a comparison between palopegteriparatide and the specified appropriate comparator therapy.
- Overall assessment
- The results of the randomised, double-blind, placebo-controlled Phase III PaTHway study are available for the assessment of the additional benefit of palopegteriparatide.
- The results of the submitted PaTHway study are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy.
- Consequently, additional benefit from palopegteriparatide for the treatment of adults with chronic hypoparathyroidism who are eligible for parathyroid hormone replacement therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Palopegteriparatid (1) | Yorvipath® | Ascendis Pharma Endocrinology GmbH | Chronic hypoparathyroidism, parathyroid hormone (PTH) substitution therapy | 18,300–20,800 | 100% additional benefit not proven Orphan |
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