We were hoping for an August approval, but it seems the FDA is making Biogen Idec's day. Two products approved in two and a half months! Both with extended half-life. Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is the newest factor VIII product.
A new era of hemophilia treatment has begun. I read somewhere that the last truly "new" product that was introduced was Advate, in 2002. True?
The hemophilia industry is big, with much at stake. The introduction of two new products, with distinct and so far unique, differences, may cause a shake up. And more products, with longer half-lives included, are coming.
More products give us more choice. But you have to know what it is you are choosing between. I have to say I don't think hemophilia parents and patients are as well informed as they should be. I just conducted a recruitment of patients and caregivers this past week, looking for those who use "plasma-derived" products ONLY. I couldn't believe the number of people who called to participate who use recombinant. They asked: what does plasma-derived mean? Isn't the product I am using plasma-derived because it contains Albumin? Or worse, arguing with me that a recombinant product is plasma-derived.
We've written so many articles describing the difference between the two categories. All factor is either plasma-derived (originates from human blood) or recombinant (from human genes in the lab). The new product is a recombinant product manipulated to last longer in the blood—basically through a longer half life.