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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