Mecasermin

Summary

Mecasermin (Increlex) is a recombinant human IGF-1 approved for the treatment of growth failure in children with severe primary IGF-1 deficiency or growth hormone gene deletion with neutralizing antibodies to GH. It is administered subcutaneously and replaces the deficient endogenous IGF-1 in conditions such as Laron syndrome.

Mechanism of Action

Recombinant human insulin-like growth factor-1 (rhIGF-1) that binds and activates the IGF-1 receptor (IGF1R), stimulating intracellular signaling pathways (PI3K/Akt, MAPK) to promote anabolic effects including cell growth, differentiation, and glucose uptake; compensates for endogenous IGF-1 deficiency in patients with growth hormone insensitivity.

Routes of Administration

Goals & Uses

• Muscle growth / anabolic effectsBody CompositionLow
• Treatment of severe primary IGF-1 deficiency (SPIGFD)Growth DisorderHigh
• Improvement of insulin sensitivity / glucose metabolismMetabolicModerate
• Amyotrophic lateral sclerosis (ALS) treatmentNeurologicalLow
• Growth promotion in GH gene deletion with anti-GH antibodiesGrowth DisorderHigh

Contraindications

• Hypersensitivity to mecasermin or excipientsAllergic/ImmunologicHigh
• Closed epiphysesSkeletalModerate
• Intravenous administrationRoute Of AdministrationHigh
• Active or suspected neoplasiaOncologicalHigh

Adverse Effects

• HypoglycemiaMetabolicCommonAbnormally low blood glucose
• Injection site reactionsLocalCommon
• Acromegaloid featuresEndocrine/MusculoskeletalUncommon
• Intracranial hypertensionNeurologicalUncommon
• Slipped capital femoral epiphysisMusculoskeletalUncommon
• Tonsillar/adenoid hypertrophyENTCommon

Drug Interactions

• InsulinHighMay increase risk of low blood sugar
• CorticosteroidsModerate
• Growth hormoneModerate
• Oral antidiabetic agents (sulfonylureas, etc.)Moderate

Population Constraints

• Neonates / infants < 2 yearsPediatricRelative
• Pregnant or breastfeeding womenReproductiveRelative
• Patients with scoliosisMusculoskeletalRelative
• Diabetic PatientsMetabolicRelative

Regulatory Status

• European UnionApprovedApproved: Long-term treatment of growth failure in children and adolescents with severe primary IGF-1 deficiencyEMA approved Increlex (Ipsen); orphan medicinal product status granted.
• United StatesApprovedApproved: Growth failure in children with severe primary IGF-1 deficiency, Growth failure in children with GH gene deletion who have developed neutralizing antibodies to GHFDA approved August 2005 (Increlex, NDA 021839). Orphan drug designation. Mecasermin rinfabate (IPLEX) was also approved but withdrawn from market in 2007 following legal settlement.
• United KingdomApprovedApproved: Long-term treatment of growth failure in children and adolescents with severe primary IGF-1 deficiencyApproved via EMA pre-Brexit; recognized in UK. Subject to MHRA oversight post-Brexit.

FDA approved in 2005 under orphan drug designation for severe primary IGF-1 deficiency (SPIGFD). EMA approved (Increlex) for the same indication. Mecasermin rinfabate (IPLEX), a complexed formulation, was approved but later withdrawn from US market following patent litigation.

Evidence & Sources

No sources recorded yet.