Mecasermin rinfabate

Identification

Name
Mecasermin rinfabate
Accession Number
DB14751 / NZ8M50KKRG
Groups
Description

Mecasermin rinfabate is accepted for intense number one insulin-like increase aspect (IGF) deficiency or in sufferers with GH gene deletion who have developed antibodies to increase hormone (GH)[A176020]. Mecasermin rinfabate is much like [DB01277] in that both tablets incorporate recombinant DNA foundation insulin-like increase component 1 (IGF-1). Mecasermin rinfabate however, is already sure to recombinant DNA origin insulin-like increase issue binding protein 3 (IGFBP-three)[A12605]. The binding of IGF-1 to IGFBP-3 is stated to extend the half life and decrease the clearance of IGF-1 in patients with boom hormone resistant syndromes and low degrees of IGFBP-three although this may represent <500 sufferers international[A176065]. Mecasermin rinfabate manufactured by Insmed included under the brand name Iplex become approved through the FDA in 2005[L5722]. In 2007 Insmed withdrew their utility for a marketing authorization with the european drugs company[F4075].

Pharmacology

Pharmacodynamics

Mecasermin rinfabate promotes vertical growth in pediatric patients in a similar fashion to [DB01277][FDA Label]. [DB01277] is a biosynthetic (recombinant DNA origin) form of human insulin-like growth factor 1 (IGF-1) designed to replace natural IGF-1 in pediatric patients who are deficient, promoting normalized statural growth[A2324]. Growth hormones (GH) bind to growth hormone receptors (GHR) in the liver and other tissues, which stimulates the synthesis of IGF-1. In target tissues, IGF-1 activates the IGF-1 receptor, resulting in intracellular signals that stimulate growth [A2323]. Although many actions of the GH are mediated through IGF-1, the precise roles of GH and IGF-1 have not been fully elucidated. Patients with severe primary IGF-1 deficiency (Primary IGFD) fail to produce adequate levels of IGF-1, due to disruption of the GH pathway used to promote IGF-1 release (possible GH pathway disruptions include mutations in the GHR, post-GHR signaling pathway, and IGF-1 gene defects[A176065]. The structure of IGFBP-3 remains unsolved[A176309].

Indication

Mecasermin rinfabate was approved for treatment of severe primary insulin-like growth factor (IGF) deficiency or in patients with GH gene deletion who have developed antibodies to growth hormone (GH)[A176020]. Severe primary IGF-1 deficiency is defined by:[FDA Label] A) height standard deviation (SD) score less than or equal to 3 SD below normal B) basal IGF-1 SD score less than or equal to 3 SD below normal C) normal or above normal levels of growth hormone In 2007, Insmed (Mecasermin rinfabate's manufacturer) made an agreement with Tercica (Mecasermin's manufacturer) that Mecasermin would no longer be available for this indication but could be developed for non short stature conditions such as severe insulin resistance, myotonic muscular dystrophy, and HIV associated adipose redistribution syndrome[A176125].

Action

Mecasermin rinfabate supplies recombinant-DNA-origin IGF-1 (rhIGF-1) bound to recombinant-DNA-origin IGFBP-3. 80% of IGF-1 is naturally bound to IGFBP-3 so the binding of rhIGF-1 to rhIGFBP-3 increases the half life of rhIGF-1 compared to [DB01277]. rhIGF-1 binds to the Type I IGF-1 receptor. This receptor exerts intra-cellular signaling activity in a number of processes involved in statural growth, including mitogenesis in multiple tissue types, chondrocyte growth and division along cartilage growth plates, and increases in organ growth[A2324].