In patients with HAE, bradykinin, a protein that causes inflammation, is basically doing whatever the heck it wants, kind of like middle school students when the teacher leaves the room. Think of CINRYZE as the principal, the regulator, the harbinger of justice for all… or, more scientifically-speaking, the C1 esterase inhibitor protein that limits inflammation.
And now, research shows CINRYZE may be able to do much more.
If you’ve been diagnosed with cystinosis, chances are you’ve had, or are gearing up for, a kidney transplant. Unfortunately, not everyone is lucky enough to find a donor. And those who do aren’t even promised positive results. Oftentimes, the body will reject foreign organs and go into defense mode, attacking the invader with heavy artillery. This epic battle is known as Antibody Mediated Rejection (MRA), and it poses a significant risk to those having undergone a kidney transplant. What’s worse, this bodily response happens on a case-by-case basis and can be hard to predict preemptively.
So, what’s the good news?
Well, as reported by the European Pharmaceutical Review, Shire, Pharma developer of CINRYZE, is in the process of developing trials to study the effects CINRYZE may have on the reduction of Donor Specific Antibodies, or DSA.
You may be thinking, “That’s great. But these kind of studies always take forever, and we don’t get answers for what feels like decades.”
To that, I say, “Hey. Will you wait a second? I’m not done.”
Since there are no approved treatments, the FDA has realized CINRYZE could very well be the difference between life and death for many donor kidney recipients.
Thus, the study is set to be expedited through the FDA’s Fast Track program, as of last year. The name speaks for itself, doesn’t it? The program was designed to expedite the review process for drugs indicated for conditions greatly in need of medical attention. See, the FDA isn’t THAT bad.
Yes… we are still waiting to hear more on the approval of CINRYZE, but isn’t it fun to find out a drug approved for one condition could be approved to treat another? What a world, what a world.