Abstract

Recombinant human insulin-like growth factor-I (rhIGF-I) has been used during the past decade for the treatment of severe IGF-I deficiency resulting from growth-hormone receptor deficiency (Laron syndrome), and for growth-hormone gene deletion in which inactivating antibodies to exogenous recombinant human growth hormone have developed. In total, about 150 patients have been treated with rhIGF-I for these conditions.1–5 Data for 61 of these patients were used for US Food and Drug Administration approval of rhIGF-I (mecasermin; Increlex, Tercica, Brisbane, CA, USA) and data for another 25 patients in approval of the binary protein complex of rhIGF-I and IGF-I binding protein-3 (mecasermin rinfabate; iPlex, Insmed, Glen Allen, VA, USA), as orphan drugs.

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