Insmed launches Iplex in USA

US drugmaker Insmed has announced the nationwide availability of Iplex (mecasermin rinfabate (rDNA origin). The product was approved as an orphan drug by the Food and Drug Administration in December 2005 for the treatment of growth failure in children with severe primary IGF-I deficiency (Primary IGFD) or with growth hormone gene deletion who have developed neutralizing antibodies to GH. Iplex is the only once-daily IGF-I replacement therapy available for the treatment of severe primary IGFD, the company states.

"Insmed is very pleased to provide this novel therapeutic protein complex for the treatment of children who suffer from severe primary IGFD," said Philip Young, chief business officer. "It has been a 20-year journey for the many researchers involved in the development of Iplex and we are very gratified to finally have the opportunity to provide the only once-daily IGF-I therapy to patients in the USA."

Primary IGFD is a distinct diagnosis of short stature and is believed to affect as many as 30,000 children in the USA. A subset of these patients is classified as having Severe Primary IGFD, which is estimated to affect 6,000 children. This is a genetic or acquired condition in which patients do not generate sufficient quantities of IGF-I due to defects in the GH receptor/IGF-I pathway. In addition to the growth failure, Severe Primary IGFD can be associated with psychosocial problems. The early recognition and proper treatment ofthe disease is critical in helping patients normalize growth and metabolic function, the company explains.