A Phase II/III, Randomized, Cross-over, Open-label Trial to Demonstrate Superiority of Prophylaxis Over On-demand Therapy in Previously Treated Subjects With Severe Hemophilia A Treated With Plasma Protein-free Recombinant FVIII Formulated With Sucrose (BAY 81-8973)
Phase of Trial: Phase II/III
Latest Information Update: 01 Mar 2017
At a glance
- Drugs Octocog alfa (Primary)
- Indications Haemophilia A
- Focus Therapeutic Use
- Acronyms LEOPOLD II
- Sponsors Bayer
- 17 Mar 2016 According to a Bayer media release, Kovaltry has received regulatory approval in Canada.
- 17 Mar 2016 According to a Bayer media release, the US FDA has approved Kovaltry (Octocog-alfa) for the treatment of hemophilia A in children and adults.
- 22 Feb 2016 According to a Bayer media release, the company received marketing approval from the European Commission for Kovaltry for the treatment of hemophilia A in patients with all age groups.