INCRELEX (Ipsen Pty Ltd)
Product name
INCRELEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
220 working days (255)
Active ingredients
mecasermin
Registration type
NCE/NBE
Indication
INCRELEX (solution for injection) is indicated for the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor 1 deficiency (Primary IGFD).
Severe Primary IGFD is defined by:
- height standard deviation score less than or equal to ≤ -3.0 and
- Baseline height velocity less than the 25th percentile for bone age, based on two measurements over 12 months and
- basal IGF-1 levels below the 2.5th percentile for age and gender and
- GH sufficiency.
- Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.
IGF-1 and GH levels must be performed using validated assays with paediatric normal ranges.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.