NEW PHOSPHATE BINDER

[obsidianom]

DA Clears New Phosphate Binder Velphoro

Megan Brooks
DisclosuresDecember 03, 2013



 

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The US Food and Drug Administration (FDA) has approved sucroferric oxyhydroxide (Velphoro, Vifor Fresenius Medical Care Renal Pharma) for treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) who are receiving dialysis, according to a company news release.

Sucroferric oxyhydroxide is an iron-based, calcium-free, chewable phosphate binder.

The FDA approval was based on results of a phase 3 study involving more than 1000 patients presented earlier this year at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) 50th Congress in Istanbul, Turkey.

As reported by Medscape Medical News, the study showed that Velphoro (formerly PA21) controls hyperphosphatemia over the long term and has a lower pill burden than sevelamer carbonate, the current standard of care in patients with CKD who are receiving dialysis.


 


 
Hyperphosphatemia is a common problem in patients with CKD who are receiving dialysis. Most dialysis patients are treated with phosphate binders, but many do not achieve and maintain target serum phosphorus levels, the company notes in the news release.

"In some patients, non-compliance due to the high pill burden and poor tolerability appear to be key factors in the lack of control of serum phosphorus levels. On average, dialysis patients take approximately 19 pills per day with phosphate binders comprising approximately 50% of the total daily pill burden," they point out.

In the phase 3 study, the average daily dose of Velphoro needed to control hyperphosphatemia was 3.3 pills per day after 52 weeks. The recommended starting dose is 3 tablets per day (1 tablet per meal).

Velphoro will be launched in the United States by Fresenius Medical Care North America in 2014, the company said.
 

[Whamo]

   I'd like to try this new binder.  I'm tired of swallowing so manyt Revelas everyday.  Besides, they cause constipation.  I wonder how this new binder affects digestion?

[nursey66]

Yeh , that's a great binder , if you have tons of money to unload . I know all binders are high cost , but my hubby's neph talked about it and he actually has an RX at the Pharm we did not pick up. It is around $975 a month . And that's only if you take 3 pills a day.  From what I have seen with binders, at least for my husband, the dose always starts low & goes up in a few weeks. And as usual, there are coupons & discounts, but not if you are on Medicare !!

[Speedy1wrc]

I am currently taking Renvela as well and the constipation is a pain. Not only that, but I just hit the gap and have started paying through the nose. With the advent of the new generic form they are jacking up the price of Renvela before the bottom drops out. In the last two months it's gone up almost $300/mo.

I am waiting to see how soon the generic from Impaxx labs hits the shelves, but it won't be soon enough. I would like to try this new iron based binder, but I don't even want to know how much it will cost.

[justme15]

i'm actually taking this new binder and it is a Godsend!!! i actually enjoy taking this one. it is cherry flavored and not nearly as chalky as fosrenol. i've been taking it religiously. my dietician gave me a pysician's sample that will last a month. after that I will have to see how insurance will or will not cover it. she gave me a discount card. i  love i though, and i was getting desperate because my phos was getting high. the only things i dont like are the residue makes your teeth reddish, so make sure you drink something to wash off the residue.  and your stools....will be black.  small price to pay. otherwise i LOOOVVE it!

[Speedy1wrc]

I will see if my dietician has any samples.

[justme15]

Just picked up my 30 day supply of velphoro from the pharmacy. It was 0 dollars and free cents! (Well not really free but u know what I mean!)  My insurance is awesome!