Ultragenyx and Kyowa Kirin’s Crysvita (burosumab) Receive the US FDA’s Approval for the Treatment of Tumor-Induced Osteomalacia
Daiichi Sankyo Signs a Non-Exclusive License Agreement with Ultragenyx for Gene Therapy Manufacturing Technology
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