Shire Plc Announces Fast Track Designation For SHP607 - Quick Facts

(RTTNews) - Shire plc (SHPG, SHP.L) announced the U.S. FDA has granted Fast Track designation for SHP607 for the prevention of chronic lung disease in extremely premature infants. The SHP607 Fast Track designation is supported by preclinical data and Phase 1 and 2 studies.

SHP607, currently in phase 2 clinical development, is a recombinant human version of the naturally occurring protein complex of insulin-like growth factor 1 and its most abundant binding protein, IGF binding protein-3. IGF-1 plays an important role in the development of the fetus in the uterus.

Following the phase 2 study results, Shire initiated discussions with regulatory authorities in the United States, Europe and Japan to discuss an appropriate regulatory review pathway for SHP607. As a result of the discussions, Shire is in the process of developing a phase 2b/3 clinical trial SHP607. Shire is currently conducting a five-year observational long-term outcomes study of patients who had been enrolled in the phase 2 study.