Shots:

• The US FDA’s approval is based on two P-II studies (144wks. & 88wks. study) assessing Crysvita in 14 & 13 patients conducted by Ultragenyx & Kyowa Kirin in the US & Japan and South Korea respectively
• Results: increment in serum phosphorus and serum 1-25-dihydroxyvitamin D levels- thus improving osteomalacia. Additionally- whole-body bone scans demonstrated reduced tracer uptake with long-term treatment suggesting healing of bone lesions
• Crysvita (burosumab-twza) is a recombinant IgG1 mAb targeting phosphaturic hormone FGF23. TIO is the second FDA-approved indication for Crysvita- which is also approved for the treatment of X-linked hypophosphatemia (XLH)

Click here to read full press release/ article | Ref: Buinesswire | Image: Ultragenyx