Iplex is specifically approved to treat children with severe primary IGF-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormones.
The drug was previously given orphan drug designation which means that the company will enjoy seven years of marketing exclusivity for Iplex in its indication to treat primary IGF-1 deficiency.
“Iplex (is) the only approved once-daily IGF-1 replacement therapy available to treat children with severe short stature,” stated Dr Geoffrey Allan, president and CEO of Insmed. “Today marks the beginning of a new treatment paradigm for treating children with Primary IGFD.”
Iplex, mecasermin rinfabate, is the human recombinant of the naturally occurring protein complex of insulin-like growth factor-I (IGF-1), and insulin-like growth factor binding protein-3 (IGFBP-3).