An Open-Label, Single-Arm, Phase 3 Study to Evaluate the Effects of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH).
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 10 Oct 2017
At a glance
- Drugs Burosumab (Primary)
- Indications X-linked dominant hypophosphataemic rickets
- Focus Registrational; Therapeutic Use
- Sponsors Ultragenyx Pharmaceutical
- 10 Oct 2017 The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for review of burosumab to treat pediatric and adult patients with X-Linked Hypophosphatemia (XLH) and has granted Priority Review status. The Prescription Drug User Fee Act (PDUFA) action date for the BLA is April 17, 2018.
- 27 Jul 2017 According to an Ultragenyx media release, the FDA agreed to accept any available bone biopsy data from this study as a supportive evidence for the Biologics License Application submitted to US FDA and the company plans to include the data from the first two patients in the BLA.
- 10 Jun 2017 Biomarkers information updated