Avacopan

[Masha]

Update. There is a new conference call available at ChemoCentryx. You can access this for about the next week. Approval for Avacopan is now in the hands of the USFDA. The company is now preparing for marketing and distribution in 2021. In my case I will continue with Rituxin BUT hopefully be able to eliminate the use of the dreaded steroids. This call is about the medical challenges faced by those of us with Anca vasculitis. It is not about their financials. I would like to tell you everything that was said, but it would be best if you listened to it yourself. The speaker cuts off the line three times, but he comes back on, so stay on and he will continue. A lot of information, confirmation of what the steroids are doing to me, and well worth my time.
Be well,
Masha

[richard052018]

Masha,

I'm sure you saw this. FDA application has moved from status "submitted" to "accepted" on AVACOPAN as a NDA (New Drug Application) by ChemoCentryx. FDA sets PDUFA (drug approval) goal date of July 7, 2021.

I just had a terrible bone density scan (confirmed Osteopenia). I would love for the Pred to be in the rear view mirror, but there are still obvious concerns, especially considering some of our members here have tried this drug and had issues.

https://www.globenewswire.com/news-release/2020/09/17/2095212/0/en/ChemoCentryx-Announces-FDA-Acceptance-of-the-Avacopan-New-Drug-Application-NDA-for-the-Treatment-of-ANCA-Associated-Vasculitis.html

[Masha]

There was a recent conference call with ChemoCentryx, maker of this drug (September 17). Sounds like they are getting their sales force ready for early 2021. I read a few comments about Avacopan on this site also. I would like to hear from those people again and learn if they were in a trial study, since it has not yet been released. As stated in the conference call, a patient is decreasing prednisone while starting Avacopan. Most people who have been on significant and/or long term use have experienced side effects in the decrease. Those of us in the orphan population of GPA will not be the only ones this drug will be targeting- now they are going after the big dogs, lupus among others. After listening or reading the latest I have a positive outlook.

Masha

[richard052018]

Masha: Just hoping for the best on this. Any sort of snake oil that will work. The Pred is tearing me up and I'd personally love an alternative.

Did they mention cost and/or insurance "buy in" on their offering? I'd imagine it will cost exponentially more than Prednisone.

[Masha]

They said the cost in the conference call before this one. It was so extraordinarily high, my mind threw it away. My husband wouldn’t let me get wrapped up in that because it would be one more thing to worry about. Tomorrow I will look and see if I can find anything else about it. In order to make it accessible to us they surely must have ways of supplementing it. Richard, I think you and I worry about everything. I have called the company in California several times. If there is a pill out there to help us we WILL get it.

[Masha]

I can’t find that price. Probably a good thing, as it may create undue concerns. They must be providing a way for us to take it. We know the number of GPA patients is small, and how many are in a position to pay an extraordinary amount for medication. Given that thought and the idea that ChemoCentryx does not want their new super drug to sit on pharmaceutical shelves, I think there will be a way for patients to access it.

[me2]

There is a good chance they will have an access program for patients. Maybe not everyone would qualify but some would. I was prescribed Rituxan before it was FDA approved and my insurance company would not pay for it. The pharmaceutical company supplied it for me at no cost.
I don't know if ChemoCentryx will do that but it would be something to ask about.