Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH
Active, not recruiting
Kyowa Kirin Pharmaceutical Development Ltd
Phase 3
2019-03-07
This is phase 3b open-label, international, multicenter study to continue to monitor the
long-term safety and efficacy of burosumab in adult patients with XLH that participated in
previous clinical trials with burosumab (UX023-CL303 / UX023-CL304).
Burosumab (also known as the drug, Crysvita®) is a fully human immunoglobulin G1 (IgG1)
monoclonal antibody (mAb) that binds to and inhibits the activity of fibroblast growth factor
23 (FGF23), leading to an increase in serum phosphorus levels. This drug is already approved
for use in patients with X-linked hypophosphatemia (XLH), but not for Cutaneous Skeletal
Hypophosphatemia Syndrome (CSHS). It is hypothesized that burosumab may provide clinical
benefit to a patient with CSHS due to the common underlying feature in this patient and in
patients with XLH - abnormally elevated FGF23 in the context of low age -adjusted serum
phosphorous levels.
Burosumab (also known as the drug, Crysvita®) is a fully human immunoglobulin G1 (IgG1)
monoclonal antibody (mAb) that binds to and inhibits the activity of fibroblast growth factor
23 (FGF23), leading to an increase in serum phosphorus levels. This drug is already approved
for use in patients with X-linked hypophosphatemia (XLH), but not for Cutaneous Skeletal
Hypophosphatemia Syndrome (CSHS). It is hypothesized that burosumab may provide clinical
benefit to a patient with CSHS due to the common underlying feature in this patient and in
patients with XLH - abnormally elevated FGF23 in the context of low age -adjusted serum
phosphorous levels.
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