Posted by Michael Wonder on 12 Sep 2017
Shire receives FDA fast track designation for SHP607 for the prevention of chronic lung disease in extremely premature infants
12 September 2017 - Shire today announced that the United States FDA has granted fast track designation for SHP607 for the prevention of chronic lung disease in extremely premature infants.
SHP607, currently in phase 2 clinical development, is a recombinant human version of the naturally occurring protein complex of insulin-like growth factor 1 (IGF-1) and its most abundant binding protein, IGF binding protein-3 (IGFBP-3). IGF-1 plays an important role in the development of the fetus in the uterus.
The SHP607 fast track designation is supported by preclinical data and Phase 1 and 2 studies. The FDA's Fast Track process is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. However, it does not guarantee that the FDA will ultimately approve SHP607 or the timing of any such approval.
