ROP drug granted orphan designation
Iplex (mecasermin rinfabate), a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3) developed for the treatment of retinopathy of prematurity (ROP), has been granted orphan drug designation by the EMEA, according to a statement from Iplex developers Insmed Inc and Premacure AB.
Iplex (mecasermin rinfabate), a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3) developed for the treatment of retinopathy of prematurity (ROP), has been granted orphan drug designation by the EMEA, according to a statement from Iplex developers Insmed Inc and Premacure AB.
The orphan designation entitles Premacure to assistance and reduced fees for pre- and post-authorization activities.
Iplex is currently approved in the US for the treatment of growth failure in children. Premacure intends to launch a multicentre Phase II trial of Iplex in the ROP indication during the second quarter of this year, and to continue investigating the drug for other indications.
