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Increlex
Published
Product name
Increlex
Active ingredient
Mecasermin
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Increlex (mecasermin) was approved for the following therapeutic use:
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 ≤ -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.
How this medicine works
Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF 1) produced in Escherichia coli.IGF-1 is the principal hormonal mediator of statural growth. Under normal circumstances, growth hormone (GH) binds to its receptor in the liver and other tissues and stimulates the synthesis/secretion of IGF-1. In target tissues the Type 1 IGF-1 receptor, which is homologous to the insulin receptor, is activated by IGF-1, leading to intracellular signalling which stimulates multiple processes leading to statural growth. The metabolic actions of IGF-1 are in part directed at stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports growing tissues.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Increlex was considered favourable for the therapeutic use approved.
Sponsor