A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study with Open-Label Extension to Assess the Efficacy and Safety of KRN23 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.
- 11 Sep 2017 24-week data from this trial presented at the American Society for Bone and Mineral Research (ASBMR) 2017 Annual Meeting, according to an Ultragenyx Pharmaceutical media release.
- 24 Aug 2017 According to an Ultragenyx Pharmaceutical media release, the company has submitted a Biologics License Application (BLA) with the Food and Drug Administration (FDA) for burosumab to treat X-Linked Hypophosphatemia (XLH) in the US. The FDA will evaluate the submission and will decide on whether to accept it within 60 days, at which time the Prescription Drug User Fee Act (PDUFA) action date will be set.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History