NATPAR (recombinant parathyroid hormone)

ENDOCRINOLOGY - New medicinal product
Opinions on drugs - Posted on Jan 11 2019

Reason for request

Inclusion

Low clinical benefit in chronic hypoparathyroidism, but not clinical added value demonstrated in the therapeutic strategy

  •  NATPAR has been granted a MA for adjuvant treatment in adults with chronic hypoparathyroidism (HPT) that cannot be adequately controlled by conventional treatment alone.
  • It is administered subcutaneously once per day and requires dose titration according to calcaemia.

  • Its superiority over the placebo, in combination with a conventional treatment (calcium and/or active vitamin D) to achieve normalized calcaemia, with decreased oral supplementation with calcium and active vitamin D has been demonstrated.

  • The available clinical data are limited: lack of robust demonstration of quality of life and prevention of renal complications, uncertainties concerning the optimal dosage regimen and long-term tolerance. However, in the absence of any alternative validated by MA, NATPAR could represent an alternative treatment, for a very limited number of patients, should the conventional treatment fail.

 

 


Clinical Benefit

Low

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Clinical Added Value

no clinical added value

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