Attending an FDA Hearing for Pfizer’s JAK: Tofacitinib CP-690550
Three years ago, one of the first friends I made through my blog was Angie. She got into a Pfizer clinical trial for tofacitinib (then called tasocitinib). She sent me some info about the trial, but my rheum doc wasn’t interested and I didn’t pursue it.
The current excitement about Pfizer’s tofacitinib
Tofacitinib is an oral medication (i.e. pill) for the treatment of RA. RA Warrior reported on the ORAL Trials when the larger Phase 3 clinical trials began over two years ago. For the past couple of years, we’ve followed the press releases and seen the buzz about Pfizer’s JAK at ACR. Market analysts are now on the edge of their seats to see what the Arthritis Advisory Committee will recommend this week since tens of billions are at stake. The FDA usually follows the recommendations of the AAC. Speculation about when the drug could be approved will be a hot topic on the wires.
At this point, 5,000 people in 35 countries have taken tofacitinib, the first of about a dozen similar compounds in the pipeline. Tofacitinib inhibits Janus kinase (JAK), a protein which acts as a hub in the cytokine network that creates inflammation. Currently approved treatments for RA (Biologics) interfere with the receptors of various immune cells such as TNF (Humira), T-cells (Orencia), B-cells (Rituxan), or IL-6 (Actemra). Tofacitinib targets a broader phase of the inflammatory process.
The trial results seem similar to those of Biologic treatments. However, Pfizer has tested tofacitinib in patients who did not respond to TNF inhibitors, indicating that perhaps a different set of patients can be helped by this new compound. Pfizer has also conducted trials without methotrexate, unlike the Biologics which were approved with a background drug (methotrexate) in place.
The Arthritis Advisory Committee hearing for tofacitinib
The FDA Arthritis Advisory Committee will meet Wednesday May 9th. I’ll be giving an oral presentation, speaking on behalf of the Rheumatoid Patient Foundation. Click here to read the accompanying written presentation. It’s not as funny as I like to be or as academic as I’d like, but hopefully it’s what is appropriate for the occasion. I’ve also prepared slides with plenty of statistics to tell more of the story.
This interesting quote appeared in the Reuters feed, so the quote is all over the net: “”We expect a noisy meeting for tofacitinib but ultimately believe the drug will receive a positive vote from the panel and will be approved by the FDA in August,’ Chris Schott, analyst at J.P. Morgan, said in a research note.”
Not sure what “noisy” means, but it might be interesting.
One doctor who was also quoted in the feed might want to read the recent review of Consumer Reports’ RA drug recommendations: “’When we already have good treatments available, and there’s no evidence that this drug really is better than others, I tend to encourage patients to go with what I know, which is things like Humira or (Amgen’s) Enbrel,’ said Dr. Scott Zashin, clinical professor of medicine at the University of Texas-Southwestern Medical School.”
Stay tuned, folks! It’s definitely not going to be boring!
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Recommended reading
- Pfizer’s JAK inhibitor Tofacitinib EMA Application Validated
- Tofacitinib / CP-690550 aka Tasocitinib Succeeds in Pfizer’s 2nd Phase 3 Trial
- Rheumatoid Arthritis Drug Trials for Tasocitinib aka CP-690550
Kelly, Am I correct in my understanding that this drug does NOT diminish the immune system as do the current biologics? I finally was put on Enbrel, despite my propensity for major infection, simply because my PsA has been so horribly aggressive. The Enbrel has helped a bit (not as much as I would like)but in the two months or so that I’ve been on it, I’ve had pneumonia and now facial cellulitis. Looks like the doc is going to nix the Enbrel….It would be great if I could take this new drug —is it also good for PsA?
rawarrior Great job on your presentation! I know you will be fantastic. I just wish I could be a fly on the wall!
Just had to tell you that I read your statement and was very impressed with the clarity and eloquence of your remarks. We are lucky to have you to represent us. Thanks!
Marvelous job. Know that if we could your faithful followers would be there with a standing ovation after your presentation – and though I cannot clap I would use my “teacher” whistle to show my appreciation. Thank you for being our voice.
You go girl! Thank you for well representing us!
Jodi
Kelly–Great job. The doc you referenced, Zashin, used to be my Rheumy. I couldn’t brush my teeth, walk, or care for my newborn and other two kiddos—but he “wanted to stick with what he knew”. I changed docs, and now I take actemera and am in complete remission….Be noisy Kelly!!
Thank you so much for the important work you are doing. May your joints be supple and your inflammation low!
aww, that’s sweet! I hope it’s easier than I anticipate. Dreading the “chair” – the dress! missing my sofa already!! 🙂
We already have perfectly good RA treatments in our current biologics so no reason to approve and try this new treatment?! Really?
This sounds pretty worth trying to me! I’d sure want the chance when I need to switch. And I’d sure want my Dr. to be willing to see if I’d want to try it.
“Sticks with what he knows”……that would be fine if what he knows works great. Sounds like this Dr. (and probably plenty more) are pretty clueless!
Glad you are going to advocate for all of us, Kelly!
that’s how it sounded to me too. I know enbrel & humira too, but I’m immune to one & allergic to the other. I’ll take something new if I get another shot at it! So much evidence that we respond differently you’d have to have your head in the sand to think otherwise.
Can you take this new medicine “tofacitinib” with a Biologic or do you have to take it instead of a Biologic?
Jewell
Kelly, I just want to address specific sentences in the above article. Hope you don’t mind.
1. She sent me some info about the trial, but my rheum doc wasn’t interested and I didn’t pursue it. Since that time, have you reconsidered? If not, why not?
2. One doctor who was also quoted in the feed might want to read the recent review of Consumer Reports’ RA drug recommendations: “’When we already have good treatments available, and there’s no evidence that this drug really is better than others, I tend to encourage patients to go with what I know, which is things like Humira or (Amgen’s) Enbrel,’ said Dr. Scott Zashin, clinical professor of medicine at the University of Texas-Southwestern Medical School.” This comment makes my physically ill. “Good treatments” available. Good for some. Very bad for others-including me. I developed multiple sclerosis after my third (3) infusion of Remicade. I received a letter from S. ? Johnson,…one of the Johnson & Johnson companies, can’t recall the exact company, saying they were very sorry, they would report it to the FDA. To my doctor they wrote there had been other reports of central nervous system disorders reported, but there was less than a 1% chance-very low risk. Does anyone have any clue what having MS and RA is like? Who treats this? What are the treatments? How does one know they are going to be sensitive to a mouse protein? Humira? no. Human protein instead of mouse. Lesions continued. Nothing worked including Rituxan, Orencia…name it-until this drug trial of CP-690-550. There’s no cure, so far, for either RA or MS, but this is the only drug that has reduced the flares/exacerbations; slowed the disease down; lowered my SED rate to almost nil; allowed me to get out of the wheelchair and use my legs; and on and on. Will we find out 10 years from now that it causes something even worse? Possibly, but for today and for the past 22 months I have not been RA’s victim.
I hope it is approved; we need all the help we can get. Everyone’s RA is different, and if there needs to be 100 different medications to treat 100 different people, then so be it. Frankly I am not very optimistic that there will ever be a “miracle cure”. Of course I hope I am wrong about that.
Best of luck with your presentation. I know you will knock their socks off, Kelly.
Kelly,
Get down with your bad self and knock ’em dead. And thank you so much for doing this.
hahahhahaha. thank you!
Kelly – I guess I’m a fortunate RA’er since I’m still working and doing most of what I used to, but this disease could change for any of us at any time. I’m so glad to have you out there fighting for all of us. Keep up the great work. And I thought your statement was fantastic- great mix of data and stories of the the patients. Keep fighting!!!
Thank you, Colleen. I hope you continue to do well & respond to treatments when needed!
Thank you for writing this blog, for accumulating so many testimonials on this terrible and unpredictable disease,for speaking for us. You are a true warrior!
Gentle hugs,
June
Thank YOU, June. I so appreciate your comments – that’s exactly it – unpredictable, REAL RA v. rare, textbook, mild, “Women’s Day RA.”
I noticed you’ve placed your email address into your comment where it can be seen by all. I’m going to delete that, but please let me know if you really want it there. Thanks.
I am not sure of the name yet, but am hopeful I will be accepted in a trial for an oral medication. I have never taken a biologic, so I am a different kind of candidate. I have not been convinced that I should take these stronger drugs yet. My methotrexate doesn’t seem to do anything except make me very tired. The progression of the disease doesn’t seem to have stopped with this med. This new trial drug is not taken with methotrexate. I should know in the next couple of weeks if I am in. Hopefully, this might be the silver bullet everyone of us needs. Hope I can help.
Good luck with it, Anna!
I have RA and my hubby has PsA and psoriasis. He is on a trial of this drug in Australia specifically measuring the effects on the psoriasis and has had amazing results with that. It doesn’t seemed to have helped the arthritis as much for him yet but that doesn’t mean it won’t help others. Once it is released here it is quite possible that I may end up taking it for my RA. I agree that doctors need to embrace these new drugs and accept that current treatments don’t work for everyone. Imagine if 15 years ago the doctors said that MTX was good enough for everyone and there was no need to prescribe any biologics!
Hi,
What are the dates of the presentation and when did this drug go before the board for approval?
Thanks,
Linda
Hi Linda, the FDA hearing already happened. It was on May 9th (stated in this post). All of the presentations were made at that time and the advisory committee voted at the end of that day. The results of the vote are reported here on the May 15th post: https://www.rawarrior.com/aftermath-of-the-fda-vote-on-pfizers-ra-jak-inhibitor-tofacitinib/
From what I hear, the FDA will make the decsion some time later this year, possibly this summer.
FDA has provided an anticipated Prescription Drug User Fee Act date of November 21, 2012.
yes, that’s what I posted yesterday on FB & twitter – not surprising, is it?
You have my admiration Kelly. Absolutely we need new drugs the old ones Enbrell my friend nearly died on got to her nervous system, Humira not crash hot either Orencia ditto.
I think it wrong to suppress the whole immune system and makes me vulnerable to all viruses, flu, colds + infections etc.
During winter I cannot go public places, no supermarkets, shopping malls etc for fear of infection.
YES PLEASE to XELJANZ JAK inhibitor – make it soon I need something to come along and save me.
I am also a patient since 2008 that has to rely on prednisone, mobic and pain killers to just have a good day every once in a while. I have been on methotrexate from the beginning with humira, then simponi, remicade, Orencia and now rituxan….I hurt just as much, if not more. I have RA in all my joints (the only ones that dont hurt often are my elbows). I am so worried about
Going back to my Rheumy in June to tell her I’m not
Going to take the rituxan again in sept. Afrer rituxan, I lived on phenegran for a month then when that subsided….I now have panic attacks. I have never had them before in my life. It
Seems as tho drs never want to admit the side effects are from the infusions!!! I always try to be positive and optimistic!!’ Every time!!’