US Phase III clearance moves Green Cross' Factor VIII closer to global market
This article was originally published in Scrip
Green Cross is looking to broaden the geographical horizons for its recombinant coagulation Factor VIII product GreenGene F (beroctocog alfa), which it views as a key growth product over the mid-term period.
The South Korean firm has just received US FDA approval of an investigational new drug application that will allow the start of US Phase III clinical trials for bleeding episodes in patients with haemophilia A. This forms part of a planned international development programme that will also include sites in the EU and is aimed at securing marketing authorisations in major markets over the next few years.
Patients with the inherited disorder lack the Factor VIII protein that plays a critical part in the blood clotting process. The US Centers for Disease Control and Prevention estimates the total number of haemophilia in the US to be around 20,000.
GreenGene F was first approved in South Korea in 2010. The B domain deleted preparation, a next-generation version of its previous GreenGene preparation, is produced using a serum- and albumin-free manufacturing process, including several pathogen inactivation steps, while a patented amino acid combination rather than albumin is used to stabilise the final formulation. These all reduce the risk of contamination while improving purity and homogeneity, Green Cross states.
Other recombinant Factor VIII products already on the market include Pfizer's albumin-free ReFacto AF (moroctocog alfa), which uses a synthetic peptide ligand free of animal materials and includes an anti-viral filtering step.