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Ultragenyx and Kyowa Kirin Announce U.S. FDA Approves Label Update for Crysvita® (burosumab) for the Treatment of X-Linked Hypophosphatemia (XLH)
Expanded Label Includes Additional Clinical Data Highlighting Superiority Over Conventional Therapy for Pediatric Patients and Extends Current U.S. Indication
About this update from Ultragenyx Pharmaceutical Inc.
[{"type":"text","content":"Expanded Label Includes Additional Clinical Data Highlighting Superiority Over Conventional Therapy for Pediatric Patients and Extends Current U.S. Indication to Patients Aged Six Months and Older\n\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n\n Expanded Label Includes Data Demonstrating Improvement in Stiffness, Continued Further Healing of Fractures and Maintenance of Efficacy with Longer-Term Treatment in Adults NOVATO, Calif., and TOKYO, Sept. 30, 2019 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare diseases, and Kyowa Kirin Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Crysvita® (burosumab). The label has been updated to include new clinical data demonstrating superiority of treatment with Crysvita versus oral phosphate and active vitamin D (conventional therapy) in pediatric patients with XLH, and improvement in stiffness, and maintenance of efficacy of Crysvita in adult patients with longer-term treatment. The indication has also been expanded to include infants as young as six months of age. Crysvita is an antibody that binds to and inhibits the biological activity of fibroblast growth factor 23 (FGF23), restoring renal phosphate reabsorption and increasing the serum concentration of 1,25 dihydroxy vitamin D. It was first approved in the U.S. in April 2018 for the treatment of XLH in adult and pediatric patients one year of age and older. “We are pleased that the updated Crysvita label includes compelling results from a controlled clinical trial demonstrating that Crysvita is significantly more effective than conventional therapy in normalizing phosphorus levels, reducing rickets and lower leg deformity, and improving growth in children with XLH. Furthermore, longer-term data from a study in adults are included showing important sustained Crysvita efficacy in this life-long disease,” said Camille L. Bedrosian, M.D., Chief Medical Officer of Ultragenyx. “As part of our commitment to support the XLH community, we worked closely with the FDA to update the prescribing information for Crysvita so physicians could make more informed treatment decisions for their patients with XLH and ensure that younger patients could be treated as this ...