SIGNIFOR (pasireotide), somatostatin analogue
RARE DISEASE - New medicinal product
Opinions on drugs - Posted on Sep 10 2015
Reason for request
- These new forms of SIGNIFOR, administered by intramuscular injection and at high dosages (20 mg, 40 mg and 60 mg) have Marketing Authorisation in the treatment of acromegaly in adult patients in whom surgery is not conceivable or who did not respond to surgery and who exhibit inadequate control with other somatostatin analogues.
- At the end of 6 months of treatment, 20% of patients treated with SIGNIFOR at a dose of 60 mg obtained control of the laboratory parameters (GH < 2.5 µg/l and normalisation of the level of IGF-1)
- Its safety profile is similar to that of other somatostatin analogues, with the exception of events linked to the carbohydrate metabolism, particularly diabetes, which are more frequent and more serious on SIGNIFOR.
Clinical Added Value
|no clinical added value||
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