Insmed Incorporated received an approval from the US Food and Drug Administration for Iplex (mecasermin rinfabate (rDNA origin) injection) for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralising antibodies to GH. As an orphan drug, Iplex is entitled to seven years of marketing exclusivity for the treatment of Primary IGFD.
"We are very pleased Iplex was approved, making Iplex the only approved once-daily IGF-1 replacement therapy available to treat children with severe short stature. This marks the beginning of a new treatment paradigm for treating children with Primary IGFD. I am grateful to all who have made this drug approval possible. This is also an exciting transition for Insmed as we now begin to focus on the commercialisation of Iplex, which we expect to launch during the second quarter of calendar year 2006," stated Geoffrey Allan, president and chief executive officer of Insmed.
Andreas Sommer, chief scientific officer of Insmed said, "This event marks the end of a long road and two decades of hard work by hundreds of dedicated people. I'm thrilled that our visionary efforts have now culminated in making available a novel therapeutic composition for the treatment of children who suffer from Primary IGFD."
"It is gratifying to see that a company who cares for the needs of patients has developed a needed therapy that allows physicians to treat children with Primary IGFD. From my experience in treating these types of patients, Iplex therapy has produced improvements in growth rates while providing an excellent safety profile" said Louis Underwood, professor of paediatrics, University of North Carolina, and a principal investigator and a member of Insmed's pivotal trial steering committee.
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).
Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs.