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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