Ultragenyx and Kyowa Kirin’s Crysvita (burosumab) Receive the US FDA’s Approval for the Treatment of Tumor-Induced Osteomalacia

 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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