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Ultragenyx's Setrusumab Receives FDA Breakthrough Therapy Designation
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Ultragenyx's Setrusumab Receives FDA Breakthrough Therapy Designation
Oct 7, 2024 5:42 AM

08:28 AM EDT, 10/07/2024 (MT Newswires) -- Ultragenyx Pharmaceutical ( RARE ) said Monday that the US Food and Drug Administration has granted breakthrough therapy designation for setrusumab to reduce the risk of fracture in patients with osteogenesis imperfecta.

The designation covers treatment for patients aged two years and older with type 1, type 3 or type 4 osteogenesis imperfecta, a group of genetic disorders affecting bone metabolism.

Breakthrough therapy designation is intended to expedite the development and review of drugs that are intended to treat serious or life-threatening diseases.

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