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Sunday, June 08, 2014

Another Product Debut: FVIII This Time!

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.
One savvy mom I've known for year, who has a son with the World's Most Stubborn Inhibitor, wrote this to me:

It's important for Biogen Idec to make clear that this product has not been tested in Previously Untreated Patients (PUPs), and the risk of inhibitors is highest in this group.

Biogen Idec will be opening up a clinical trial for PUPs and I am encouraging anyone who wishes to use the Alprolix (long-lasting recombinant FIX) in a previously untreated patient, to wait and enroll in that trial, so Biogen can gather the appropriate data to understand how safe the product will be in PUPs.

Please always speak with your HTC hematologist to learn which product is best for you or your loved one. (And I don't usually use underlines in my writing! Yeah, it's that important)

To learn more about Eloctate, visit:
http://www.biogenidec.com/therapies_eloctate.aspx?ID=20259

Good Book I Just Read
The Right Stuff by Thomas Wolfe [Kindle]

The gripping story of the origins of the space race, and the American men who volunteered to become the first Americans in space. The Mercury astronauts, made heroes by the press and NASA, possessed the character and qualities that made America proud. The book covers a lot of ground, from what it's like to sit in the cockpit, going to Mach 1, the speed of sound, the tough men who were test pilots, the culture of the test pilots, and eventually the program to put a man in space. It's a great story (and the movie is superb) and you'll learn a lot. Wolfe's flamboyant, hyperdramatic and  over-the-top style just wore on me terribly and I had a hard time eventually getting through this. Way too many exclamation points per page! Great story, odd writing though many consider Wolfe a national literary treasure. Three stars/five.


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