Increlex (mecasermin)
- Region
- 🇪🇺 EU
- Active substance
- mecasermin
- Company
- Esteve Pharmaceuticals, S.A.
- Status
- Authorised
- Therapeutic area
- Laron Syndrome
- EU approval
- Thu 02 Aug 2007
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/000704
- ATC
- H01AC03
- Official record
- www.ema.europa.eu
Indication
For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary IGFD). Severe primary IGFD is defined by: height standard deviation score ? -3.0 and; basal insulin-like growth factor-1 (IGF-1) levels below the 2.5th percentile for age and gender and; growth hormone (GH) sufficiency; exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Severe primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signalling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Iplex Application withdrawn · Insmed Europe Ltd
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