(RTTNews) - Ultragenyx Pharmaceutical (RARE) has received Breakthrough Therapy Designation from the FDA for setrusumab as a treatment to reduce the risk of fracture associated with osteogenesis imperfecta Type I, III, or IV in patients 2 years of age and older. The decision was based on preliminary clinical evidence including the positive 14-month results from the Phase 2 portion of the Orbit study.
Setrusumab was granted Orphan Drug Designation in the United States and EU, rare pediatric disease designation in the United States, and accepted into the European Medicine Agency's Priority Medicines program.
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