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.