Avacopan

[seied]

What happened
Shares of ChemoCentryx (NASDAQ: CCXI) suffered an ugly 79% plunge in May, according to data provided by S&P Global Market Intelligence, after a Food and Drug Administration advisory committee offered up a split opinion on the efficacy of avacopan, the biotech's treatment for antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV).


So what
The panel generally leaned in favor of the treatment, voting 10-8 in support of avacopan's safety profile and its benefit-risk profile in treating adult AAV patients, but it split 9-9 on whether the efficacy data supported approving avacopan for treating them.

https://www.nasdaq.com/articles/why-...may-2021-06-04

[Masha]

A new PDUFA date has been set for on or before October 7th. The reason given for the tie vote in July was that they felt enough time was not given in the last trial.
I wouldn’t doubt if there were lobbyists involved in the delay. The approval of this drug will not be good for the sales of prednisone. I read one article that said Avacopan and Prednisone were about equal in treatment. I felt what was sorely missing was that they may work equally but many of us have suffered the ill effects of prednisone.
My crystal ball is in for repairs, so it would only be a guess when this will be available to us.
In the meantime, I am doing a slow wean from prednisone.

[J@$0N]

A new PDUFA date has been set for on or before October 7th. The reason given for the tie vote in July was that they felt enough time was not given in the last trial.
I wouldn’t doubt if there were lobbyists involved in the delay. The approval of this drug will not be good for the sales of prednisone. I read one article that said Avacopan and Prednisone were about equal in treatment. I felt what was sorely missing was that they may work equally but many of us have suffered the ill effects of prednisone.
My crystal ball is in for repairs, so it would only be a guess when this will be available to us.
In the meantime, I am doing a slow wean from prednisone.

I guess this is why I'm so hesitant about the experimental vaccine. It takes so long for medication such as this to get out and approved, and it was out in less than a year and possibly approved by Sept. This condition is definitely not simple. Thank you for updating!

[KathyTPA]

Hi, does anyone know the side effects for Avacopan? I could not find any, and I was told they will not publish that until approval. Pred has damaged my bones, it was so beneficial for in intial diagnosis and the flare I had recently.

[Pete]

From the Vasculitis Foundation: https://ir.chemocentryx.com/news-rel...-avacopan-anca

[Masha]

Disappointed. All along they said it was to replace steroids. Not what they are saying now. Cost is $150,00 to $200,000 year. It is now being presented as a drug to help patients near organ failure. I will keep trying to reduce prednisone on my own. Made it to 7 1/2.

[J@$0N]

Wow.. that is extremely disappointing. It is all about the money!

[Razie]

Hello all,

I have recently been diagnosed with GPA. Had 2 rounds of Truxima, and am tapering off prednisone, currently at 20mg/day. My rheumatologist has suggested Tavneos/Avacopan with the hope that it will replace the prednisone. I can't find any recent information on this drug; even the posts on this forum seem sparse for recent news. Is anyone on this drug? What is your experience with regard to getting/staying in remission, side effects, anything else I should be considering?

Thanks,
Razie

[drz]

Hello all,

I have recently been diagnosed with GPA. Had 2 rounds of Truxima, and am tapering off prednisone, currently at 20mg/day. My rheumatologist has suggested Tavneos/Avacopan with the hope that it will replace the prednisone. I can't find any recent information on this drug; even the posts on this forum seem sparse for recent news. Is anyone on this drug? What is your experience with regard to getting/staying in remission, side effects, anything else I should be considering?

Thanks,
Razie

it is very expensive ( about $17000 a month) so even with a good drug insurance plan the co- pay might run close to a $1000 a month but I qualified for free monthly shipments and took it for several months. It caused such a decline in my immune system that I developed three infections and had to stop it. My doctors decided it was not worth the risk to try go back on it. Pneumonia and bladder infections are most common from it. The other side effects from it were tolerable after a period adjustment to it.

[Razie]

Yikes! That doesn't sound very promising. So sorry to hear you had such a bad reaction.