PARSABIV (etelcalcetide), anti-parathyroid agent
NEPHROLOGY-ENDOCRINOLOGY - New medicinal product
Opinions on drugs -
Posted on
Jan 10 2018
Reason for request
Inclusion
No clinical benefit demonstrated in the treatment of secondary hyperparathyroidism in adult patients on haemodialysis compared to MIMPARA.
- PARSABIV has Marketing Authorisation for the treatment ofsecondary hyperparathyroidism (SHPT) in adults with chronic kidney disease (CKD) on haemodialysis therapy.
- In one randomised comparative study versus MIMPARA, the percentage of patients who had a decrease of >50% of the mean parathormone (PTH) level compared to baseline and those having a decrease >30% was greater in the arm treated with PARSABIV.
- Hypocalcaemia and cardiac disorders were more frequently observed in the arm treated with PARSABIV.
Clinical Benefit
Substantial |
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Clinical Added Value
no clinical added value |
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English version
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