Currently, recombinant BMPs are the only biologic factors approved for use in bone repair therapies; however, whereas BMPs can promote ossification, their clinical efficacy is controversial (Garrison et al., 2010).
Recombinant factor IX Fc (rFIXFc) fusion protein is the first of a new class of bioengineered long-acting factors approved for the treatment and prevention of bleeding episodes in haemophilia B. The aim of this work was to describe the manufacturing process for rFIXFc, to assess product quality and to evaluate the capacity of the process to remove impurities and viruses.
At the moment, it represents the only growth factor approved by American and European authorities for use in the treatment of foot ulceration.
Bevacizumab is an anti-vascular endothelial growth factor approved in association with paclitaxel or docetaxel as first line in patients (pts) with metastatic breast cancer.
Later on, inhibitors targeting receptors for epidermal growth factor or vascular endothelial growth factor were approved for treatment of solid tumors, such as lung and breast cancer.
Becaplermin, a recombinant human platelet-derived growth factor-BB (Regranex, PDGF-BB, Systagenix Wound Management, Gargrave, UK) is the only growth factor preparation approved by the FDA for treating DM ulcers, but it requires daily applications for weeks to months [ 4, 5].
PDGF, sold under the brand name Regranex®, is the only growth factor currently approved by the FDA and is intended for the treatment of lower extremity diabetic ulcers.
Becaplermin is the only growth factor currently approved for use in diabetic foot ulcers (Papanas and Maltezos 2007).
Kcentra™ (CSL Behring, King of Prussia, PA, USA) is the first inactivated four-factor PCC approved by the US Food and Drug Administration to correct warfarin-related coagulopathy.
Ranibizumab and aflibercept are alternative anti-vascular endothelial growth factor agents approved for the treatment of visual impairment (VI) due to diabetic macular edema (DME).
Bevacizumab, a recombinant human monoclonal antibody targeting vascular endothelial growth factor, was approved for first-line treatment of patients with advanced CRC by the EMEA, in early 2005, based on the data from the phase III AVF2107g trial (Hurwitz et al, 2004), which showed an increased response rate (RR), with an improved median duration of survival and a longer median PFS.
