A Randomized, Open-Label, Dose Finding, Phase 2 Study to Assess the Pharmacodynamics and Safety of the Anti-FGF23 Antibody, KRN23, in Pediatric Patients With X-linked Hypophosphatemia (XLH)
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 15 Dec 2017
At a glance
- Drugs Burosumab (Primary)
- Indications X-linked dominant hypophosphataemic rickets
- Focus Adverse reactions; Pharmacodynamics; Therapeutic Use
- Sponsors Ultragenyx Pharmaceutical
- 15 Dec 2017 According to an European Medicines Agency media release, as part of the conditional marketing authorisation, the applicant is required to complete three ongoing studies to further investigate the safety and efficacy of the medicine.
- 15 Dec 2017 According to an European Medicines Agency media release, the CHMP recommended granting a conditional marketing authorisation for Crysvita(burosumab), for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children and adolescents with growing skeletons.
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History