An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia A
Phase of Trial: Phase III
Latest Information Update: 18 May 2017
At a glance
- Drugs Efmoroctocog alfa (Primary) ; Factor VIII stimulants
- Indications Haemophilia A
- Focus Registrational; Therapeutic Use
- Acronyms Kids A-LONG; Kids ALONG
- Sponsors Biogen
- 18 May 2017 Based on the data from this and the A-LONG trial, the Saudi Food & Drug Authority (SFDA) in the Kingdom of Saudi Arabia approved Elocta (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life, for the treatment of haemophilia A, according to a Swedish Orphan Biovitrum media release.
- 06 Dec 2016 Results of long term safety and efficacy analysis from ASPIRE and Kids A-LONG studies presented at the 58th Annual Meeting and Exposition of the American Society of Hematology.
- 21 Nov 2016 According to a Swedish Orphan Biovitrum AB media release, based on the data from this and A-LONG trial, Swedish Orphan Biovitrum AB (publ) (STO:SOBI) (Sobi) today announces that the Ministry of Health in Kuwait has approved Elocta (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life, for the treatment of haemophilia A.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History