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Pete
11-29-2019, 12:24 AM
Could this be the treatment many of us are waiting for??

https://www.biospace.com/article/chemocentryx-shares-rocket-300-percent-at-positive-vasculitis-trial-data/?TrackID=15

annekat
11-29-2019, 04:05 AM
Pete, this sounds like a dream come true. I wonder if patients like me, and maybe you, who are not in "acute" Vasculitis, will be able to use it. Will be interested in knowing what your doc in Cleveland has to say about it.

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drz
11-29-2019, 11:03 AM
It will be interesting to see who offers this treatment first after it gets clearance from FDA! It may take a year or two before any of us see it.:sad:

Mnjet
12-01-2019, 08:36 AM
Could this be the treatment many of us are waiting for??

https://www.biospace.com/article/chemocentryx-shares-rocket-300-percent-at-positive-vasculitis-trial-data/?TrackID=15



Thanks for the article Pete! Very exciting news for us!

sshiveley
12-11-2019, 01:36 AM
This drug sounds exactly like many of us need! Would love to be in the trial of this, hope is on the agenda for a cure for all of us. Sherry

richard052018
01-19-2020, 05:59 AM
Pete: I just read about this drug. My first reaction (even before telling my wife) was to see if it was mentioned on this board. It was, because of course, this is the best resource for GPA news on the internet.

Take Care.

Masha
01-19-2020, 08:31 AM
Am I understanding this correctly? When used with Rituxin there may be no more need for prednisone? I am so excited at the thought of this I could be misinterpreting what I am reading. Some articles say it should be approved in Europe and by US FDA in 2020. What are your thoughts? When do you think we will really get it? Life without prednisone would be a dream come true

Pete
01-19-2020, 09:02 AM
Masha

As I re-read the article, I saw no mention of rtx. Avacopan apparently induces remission all by itself — no steroids needed. When I next see Dr Villa Forte (probably this fall), I’m going to ask her about avacopan. If it can be used instead of rtx AND it’s priced reasonably, I hope I can use it.

vdub
01-19-2020, 09:07 AM
When used with Rituxin there may be no more need for prednisone?
That's the way I read it, Masha. No pred would definitely be nice. However, surely there are some side-effects with this drug. Let's just hope they aren't bad.

Masha
01-19-2020, 11:04 AM
In an article Nov 27, 2019 from ANCAVASCULITUS. (I googled it) it refers to limiting steroids and using avacopan in conjunction with Rituxan. I am on information overload.
My husband just said if it passed its 3rd trial it is pretty much a done deal.
Like vdub says, how do we know how we will react to this drug. It will probably be different for all of us. We differ with methotrexate, azathiopran, Rituxin. I will be seeing my Duke doctor in a month and a half, but as I have said before she is retiring, so who knows.
This site really is a wealth of knowledge. Thanks for sharing. If I confuse myself, I now have two excuses. I have GPA. I am a septuagenarian.:flapper:

annekat
01-19-2020, 02:19 PM
I suppose it could depend on severity of disease, some might still need RTX, but maybe people who haven't needed RTX (like me) could still get by without it. Pure speculation. I posted the article on a Facebook vasculitis group and people went nuts with joy, but there's a lot we still don't know. I also read it as vdub and Pete read it. But someone on FB said they thought it wouldn't make RTX unnecessary. People in England have apparently heard a lot more about it, and the trials that were conducted, than we have. A couple of them were discussing between themselves about whether they should buy stock in the company. I'll be waiting to hear what Dr. Villa Forte has to say, Pete.





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Masha
01-22-2020, 02:06 PM
Hey Y’all,
I am like a dog with a bone regarding avacopan.
Found an interesting article by looking at Chemo-centryx Motley Fool. My husband found their 3rd Q conference call, too. That was very long and a lot about their financials. What I did find of interest in the second article were the two doctors who joined in, Dr. John Nash, Mass General and Dr. David Jane, Cambridge. It seems I heard the name Dr. Jane on this site from one of our members. Who?
Looks like the drug will be released at the end of 2020, start of 2021.
Chemo-centryx the US company for this drug is in Mountain View, CA. My husband got a kick out of it when I told him I may call them tomorrow and tell them there are those of us waiting for them to get this show on the road.
The first article refers to us as patients with an orphan disease. My guess is we are only the beginning. No one would put this much money (see conference call) into something for orphans.
Your thoughts?
Masha

Pete
01-22-2020, 02:37 PM
There are several UK folks on here who see Dr Jayne at Addenbrookes in Cambridge. Geoff, Freakyschizogirl among them.

I’m very interested in this drug. Hoping it’s a lower cost alternative to rtx, mtx, and ctx. Curious about side effects too.

annekat
01-22-2020, 02:50 PM
Hi, Masha,
Yes, Dr. David Jayne was mentioned in the article posted by Pete at the beginning of this thread. But he has been mentioned many times on this forum over the years, at least since 2011 when I joined. That's because several of our members in England have gone to him, and still do, for their GPA treatment. Unfortunately for us, some of these no longer, or rarely, post here, though I know they post in some of the Facebook GPA groups. Anyway, he is known worldwide as a GPA expert.

Sorry, I don't have much to speculate on whether there are others, not "orphans", who would be benefitting from avacopan, though I imagine there would. I think probably all the drugs we use are used in treating other diseases, some autoimmune, some maybe not. But I think knowing that Dr. Jayne is involved would indicate that the trials on this drug were done with us largely in mind.

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annekat
01-22-2020, 04:17 PM
Hi, Pete,
I posted the article on one of the GPA Facebook groups and got a big reaction, with lots of interest and speculation (as I posted above). Some of them seemed to have some knowledge of it, from observing round-table discussions, seeing news items in the UK, etc. They seemed to be of the mind that it wouldn't take the place of Rituxin, but would just eliminate the need for prednisone. Well, I don't take Rituxin, so I wonder where that leaves me. The article implied to me that avacopan could stand alone. But it mainly compares it to prednisone, not mentioning Rituxin or any of our other immunosuppressants. However, then it quotes Thomas J. Schall, president and chief executive officer of ChemoCentryx as saying it's been demonstrated to be "superior to the traditional approach of broad immune suppression therapy; a therapy which the present findings may make obsolete." Broad immune suppression therapy, for us, would include RTX, CTX, MTX, etc., as well as prednisone, wouldn't it? So, I think the article is a little deficient in that regard, by only naming prednisone and none of our other meds. And Dr. Jayne wasn't quoted as mentioning any drug but prednisone, either. I guess we will have to wait and see.

Oh, and Masha, the article said the FDA had granted it orphan drug designation for vasculitis and a couple of other diseases I hadn't heard of. For whatever that's worth.

Anne

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Keith
01-23-2020, 01:41 PM
From Wikipedia (because I didn’t know)


An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases.



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Pete
02-24-2021, 10:29 AM
Looks like avacopan will be approved to treat ANCA Associated Vasculitis soon.

https://www.globenewswire.com/news-release/2021/02/17/2177540/0/en/ChemoCentryx-Announces-Publication-in-The-New-England-Journal-of-Medicine-of-Results-of-the-Pivotal-Phase-III-ADVOCATE-Trial-of-Avacopan-for-the-Treatment-of-ANCA-Associated-Vascul.html

richard052018
04-20-2021, 05:34 AM
Bummer on the Avacopan front

Per Dr. Villa Forte (met with her this week), she believes that if Avacopan gets FDA Approval, it will be approved for treatment of active disease to induce remission, but not as a long term maintenance drug for patients already in remission. Right now, there isn't enough data available to support usage for long term remission maintenance replacing prednisone. That doesn't mean the data won't exist in the future, but it does not exist right now.

This is heartbreaking.

me2
04-21-2021, 03:12 AM
Hopefully they will work on another study that will establish it for maintenance use- of course that would take a while. If it could be a substitute for steroids in broader usage though I'm thinking it would be a priority for the company as it would be a VERY successful drug that can replace steroid use.

J@$0N
08-12-2021, 12:29 PM
Any updates to this medication? It has been almost one year since diagnosis and I don’t know if I’ll ever catch up. Would be great to have an alternative to prednisone.

seied
08-15-2021, 02:14 PM
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-chemocentryx-stock-plunged-79-in-may-2021-06-04

Masha
08-15-2021, 03:44 PM
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
08-16-2021, 09:07 PM
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
08-20-2021, 08:46 AM
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
10-09-2021, 12:17 AM
From the Vasculitis Foundation: https://ir.chemocentryx.com/news-releases/news-release-details/chemocentryx-announces-fda-approval-tavneostm-avacopan-anca

Masha
10-11-2021, 04:32 AM
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
10-11-2021, 05:32 AM
Wow.. that is extremely disappointing. It is all about the money!

Razie
09-21-2022, 01:27 AM
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
09-21-2022, 07:52 AM
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
09-21-2022, 08:22 AM
Yikes! That doesn't sound very promising. So sorry to hear you had such a bad reaction.

drz
09-21-2022, 02:54 PM
Yikes! That doesn't sound very promising. So sorry to hear you had such a bad reaction.

A lot of people do fine on Avacopan but it did not work out well for me. If you can afford it or get it free it is worth trying and you might do fine on it for a long time with no problems. Most infections can be treated effectively so I would not view it as a high risk procedure.

Razie
09-21-2022, 10:11 PM
Thanks drz,
Do you know if folks are able to replace prednisone with avacopan, or is it more supplemental?
Thanks!
Razie

jmq
09-23-2022, 12:33 PM
I am confused. I have a question similar to Razie's question.
is Avacopan a replacement for Rituximab (or biosimilar) or a replacement for Prednisone?

Jeannette

Razie
09-24-2022, 11:16 PM
jmq, my understanding is that Avacopan, which is sold under the name Tavneos, affects a different pathway than Rituximab. It is not a biosimilar for Rituximab. I had 2 infusion treatments with Truxima, which is a biosimilar to Rituximab.

My first delivery for Tavneos/Avacopan is coming next week. My rheumatologist is having me speed up my prednisone taper; I was reducing dosage every 2 weeks, now I'll be reducing dosage every week. I'm nervous about potential side effects and adverse reactions, but that comes with pretty much any new medication I guess.

Razie

drz
09-25-2022, 07:15 AM
I am confused. I have a question similar to Razie's question.
is Avacopan a replacement for Rituximab (or biosimilar) or a replacement for Prednisone?

Jeannette

It suppresses the immune system so for me it replaced RTX infusions. My prednisone dosage was unchanged while taking it. I still had some residual signs of GPA and maybe if I could have stayed on it and the GPA ssigns disappeared, then i could have stopped the prednisone meds too.

jmq
09-25-2022, 12:12 PM
It suppresses the immune system so for me it replaced RTX infusions. My prednisone dosage was unchanged while taking it. I still had some residual signs of GPA and maybe if I could have stayed on it and the GPA ssigns disappeared, then i could have stopped the prednisone meds too.

Thank you for the info. I also submitted a question to my rheumy at Emory via their portal and this is what he said:
“ Avacopan has not been studied as a maintenance drug. The initial studies used Avacopan as a way to reduce steroids during induction therapy. Studies are still not clear as to how to best use this medication.”

CapeKay
08-22-2023, 02:35 AM
My new Doc at MGH/Boston started me on Avacopan about 6 weeks ago. His emphasis was that it would help me to get off Prednisone. I was having difficulty reducing at a very rapid rate (20mgs. in 2 weeks) and continuing at 10 mgs. every two weeks until I was off it. I am down to 20mgs. from 60mgs. However, I now am on oxygen in my house about 14-16 hours day. I had stopped using it entirely . Lung, back and shoulder pain are severe at times, and some other symptoms are returning. My fear is that I will get pneumonia because it hurts so much to breathe. Both Docs I have had monitoring this disease are determined to get me completely off Prednisone. The rep for Avacopan will not say that it takes the place of Prednisone. Nor do they claim that you can eventually get off of it if you continue with Avacopan, provided it works for you. I feel like I have lost perspective. On the one hand I have come down on the prednisone by 2/3rds. On the other hand I am very concerned with a renewed assault on my lungs, weakness in my legs etc. On a high note I really haven't had any adverse side effects, although I did read an old article that suggested one may become more vulnerable to pneumonia. Chest pain is also a side effect of Avacopan. I too often question whether symptoms are disease, or side effects from meds.

Pete
08-22-2023, 03:55 AM
CapeKay

You may want to try a very slow pred taper. It took me nine months to go from 5 mg/day to zero. I got off pred in 2018, and haven’t gone back on it as maintenance therapy since. I’ve done a couple short blasts to deal with a stress-induced mini-flare and a Covid ear issue.

CapeKay
08-22-2023, 08:47 PM
Thanks Pete. That has been my advice to the Docs. Back 12 years ago when I was being treated for GCA my doc at MIT slowed me down to reducing prednisone by 1 mg. per month. Yesterday I claimed few side effects from Avacopan. Last night I took a closer look at side effects and thought more about what has been going on with renewed symptoms with me. Aside from horrible chest pain and difficulty breathing, and return of constant runny nose, the bruising/ breaking of my skin is far worse than it has ever been. As well as hair loss which is falling out at maybe 2x the rate it had been on higher dose pred. Alopecia is a side effect of Avacopan. My understanding was that this drug could not only help me get off Prednisone, but become a substitute, without many of the side effects. I found this article from the FDA. They refer to it as an "add-on treatment, including clucocorticoids".

FDA approves add-on drug for adults with rare form of blood vessel inflammation | FDA (https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-add-drug-adults-rare-form-blood-vessel-inflammation)

Pete
08-23-2023, 09:37 PM
CapeKay

When avacopan was first being touted as a treatment for GPA, I asked my rheumy at Cleveland Clinic about it. She said that since I was off pred and doing well with rituximab, I wouldn’t benefit from it. Maybe your doc needs to take you off avacopan and increase your pred until you’re more stable at which time you could begin a slow taper?

CapeKay
08-24-2023, 09:36 AM
Thanks for the support Pete. I am waiting to hear back from Doc. I am experiencing pain in my chest and back that is nearly intolerable. I have always had a very high threshold for pain but this is beyond anything I have experienced before. X-ray showed nothing and I know that is so often the case with vasculitis. I can't tolerate NSAIDs and Tylenol is not doing much. At the same time my breathing has really deteriorated. I hope he will agree with me that Avacopan is not helping. Thanks again.

Kathy

Pete
08-24-2023, 09:58 PM
CapeKay

If you’re having difficulty breathing and chest pain, call 911 and get to the hospital. Ambulances that arrive with patients with breathing difficulty and chest pain get higher priority. I think you should see a doctor immediately. Just because you have GPA doesn’t mean you can’t have something else.

Good luck!!

Chadwyck
08-29-2023, 03:41 AM
Wow, this is awesome news!