The FDA has fast tracked Shire’s candidate for chronic lung disease in extremely premature infants from Phase 2 of clinical development.
The FDA has fast tracked Shire’s candidate, SHP607, for the treatment of chronic lung disease based on preclinical data, the results of Phase I and II studies so far, and a lack of treatments currently available. Howard Mayer, Shire’s Head of R&D said: “There are no approved treatment options for chronic lung disease for premature infants, and we are aiming to change that.” It must be noted that despite this being a positive step, there are no guarantees that it will ultimately be approved.
SHP607 is a recombinant human version of the insulin-like growth factor 1 (IGF-1) protein and its abundant binding protein, IGF binding protein-3 (IGFBP-3). IGF-1 is important in the development of the fetus, but in premature infants, levels of IGF-1 decrease before 28 weeks, which increases the risk of complications. Around 60% of extremely premature infants experience complications, and severe complications can have life-long effects. Current therapies focus on controlling symptoms, so Shire’s treatment offers new hope of remedying the condition.
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