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U.S. Food and Drug Administration approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened and softened bones.
• The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.
• FGF23 regulates levels of phosphate, an electrolyte that plays important roles in bone maintenance, energy production by cells and nerve function.
• When there is not enough phosphate in the body, bones begin to soften and weaken, causing osteomalacia (marked softening of bones).
• Most common side effects: tooth abscess (infection), muscle spasms, dizziness, constipation, injection site reaction, rash, and headaches.
• Crysvita is also FDA-approved to treat adults and children six months and older with X-linked hypophosphatemia, which causes low levels of phosphate in the blood and leads to impaired bone growth and development in children and teenagers.
• The FDA granted approval of Crysvita to Ultragenyx Pharmaceutical Inc.
Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-rare-disease-causes-low-phosphate-blood-levels-bone-softening
• The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.
• FGF23 regulates levels of phosphate, an electrolyte that plays important roles in bone maintenance, energy production by cells and nerve function.
• When there is not enough phosphate in the body, bones begin to soften and weaken, causing osteomalacia (marked softening of bones).
• Most common side effects: tooth abscess (infection), muscle spasms, dizziness, constipation, injection site reaction, rash, and headaches.
• Crysvita is also FDA-approved to treat adults and children six months and older with X-linked hypophosphatemia, which causes low levels of phosphate in the blood and leads to impaired bone growth and development in children and teenagers.
• The FDA granted approval of Crysvita to Ultragenyx Pharmaceutical Inc.
Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-rare-disease-causes-low-phosphate-blood-levels-bone-softening
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Dr. B●●●●●h F●●●a Ophthalmology
Oii
Jun 20, 2020Like
