Factor VIII biosimilar - Amega BiotechAlternative Names: Recombinant factor VIII - Amega Biotech
Latest Information Update: 15 Aug 2013
At a glance
- Originator Amega Biotech
- Class Antihaemorrhagics; Blood coagulation factors; Recombinant proteins
- Mechanism of Action Blood coagulation factor replacements; Factor X stimulants
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
On Fast track
Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.
- New Molecular Entity No
Highest Development Phases
- Phase Unknown Haemophilia B
Most Recent Events
- 15 Aug 2013 Investigation in Haemophilia B in Argentina (Parenteral)