Abbott withdraws application to market briakinumab for psoriasis
January 15th 2011 by Psoriasis Cure Now
Abbott today announced in a securities filing that it has withdrawn its application with the U.S. Food and Drug Administration (FDA) and European regulators to market its much-anticipated, experimental No prescription cialis
oriasis-treatment-medication-resources/briakinumab-abt-874-abbott”>psoriasis treatment briakinumab (ABT-874, Ozespa). The biologic, like Centocor Ortho Biotech’s Stelara (ustekinumab), targets two internal proteins linked to inflammation, IL-12 and IL-23. Briakinumab has demonstrated very powerful effectiveness in improving psoriasis symptoms, and has been the subject of much fawning coverage. Psoriasis Cure Now threw a rare splash of cold water on the proceedings in our analysis of briakinumab’s four pivotal psoriasis clinical trials. While we lauded its effectiveness, we reminded readers that “effectiveness is only one side of the equation. Patients also need treatments that are safe.” The trials raised safety concerns that we seemed puzzled were not generating attention in the health care media or among other nonprofits. Today’s announcement that Abbott has withdrawn its application, unfortunately confirms our suspicions.
In its filing, Abbott wrote: “Following feedback from regulatory authorities indicating the need for further analysis and the potential for additional studies, the company plans to evaluate next steps for briakinumab, including resubmission at a later date.” This suggests the FDA and its European counterpart want to see more evidence on the safety side of the equation for briakinumab (Ozespa). Fortunately, several studies of briakinumab are ongoing.
“We certainly hope Abbott will continue these studies and that they will demonstrate that briakinumab’s benefits outweigh its risks,” said Michael Paranzino, president of Psoriasis Cure Now and a psoriasis patient. “Psoriasis patients need additional treatment options, particularly those for whom the anti-TNF therapies have not worked or are not appropriate. Given briakinumab’s eye-catching effectiveness in clinical trials, we certainly hope this treatment option can soon become available for patients who need it. No treatment is without risk, but we can’t quarrel with the FDA, given what we know today, for wanting to see some more data. The FDA, however, must be mindful that moderate to severe psoriasis can have a devastating impact on quality of life, and other treatments also carry risks.”
Abbott’s CFO this week referred to briakinumab as a “decent product,” an unusually lukewarm description of a product that has been much buzzed about at dermatology meetings and on psoriasis message boards. Let’s hope that was designed to calm investors concerns about this announcement, and not a signal that Abbott is losing interest in this potential treatment, or that they are seeing additional data not yet released publicly that causes greater concern. A Wells Fargo analyst today predicted a “multiyear delay” for briakinumab.
For psoriasis patients, it’s a painful reminder how very hard and expensive and time-consuming it is for pharmaceutical and biotech companies to find new and better treatments that are both safe and effective. It will also put additional spotlight on Stelara’s safety record, as its mechanism of action is similar. So far, Stelara has not seen this level of concern and of course, it has already been approved by US and European regulatory bodies.
Still, the psoriasis treatment research pipeline remains robust, and there are numerous treatment options that are helping psoriasis patients right now. We won’t spin you, this is disappointing news, but there is great reason to be optimistic nonetheless.
Category: Biologics, Psoriasis Research, Side-effects of treatment
Tags: Abbott, ABT-874, Briakinumab, FDA, Stelara, ustekinumab
I participated in phase i of the trial and had very good results with no side effects.
I am on week #109 of the 156 week clinical trial. For the first time in about 57 (yes, fifty-seven) years of severe plaque psoriasis, I am 100% free of it. No side effects whatsoever! So, another good medication bites the FDA’s dust – what percentage of people on the clinical trial have or had serious side effects? Even aspirin has some – luckily, there were no approvals needed when it was introduced well over 100 years ago.
I have been in the study going on 5 yrs, with great results, no side effects, very disappointed in them concelling this study, IT DOES WORK
After 42 weeks in clinical trial, I am 100% free of severe plaque psoriasis and absolutely no side effects. I can’t imagine not having this drug. It’s a sad day that we are sooo regulated that we have no say in the decision the FDA makes. We should be able to evaluate a clinical trial based on facts and side effects and let it be our own decision whether or not we want to stay on the drug. Very disappointed.
John H. Szalkay says:
July 28, 2011 at 10:06 pm
I have been on the ABT-874 clinical trials for nearly three years. After having had severe plaque psoriasis for nearly 60 (yes, sixty) years, I am 100% free of the disease. I have had absolutely no side effects. BUT – I was notified two days ago on July 26, 2011 by the clinical trial center that Abbott Laboratories terminated the trials and will not apply in the U.S. for FDA approval. As one physician friend told me – if a manufacturer would apply today for approval of aspirin, he would be quite certainly refused.Of course some people experience side effects from ABT-874. I am on Prevastatin, the side effects include bad muscle pains – but it does control cholesterol. So, I prefer muscle pains to clogged arteries. I prefer clear skin to psoriasis. The big question: did Abbott abandon ABT-874 because it might not generate the profits it expected????
Have used Briakinumab now for over three years with amazing results. I NEVER thought that in my lifetime there would be a treatment this effective. Have had Psoriasis for 53 years. Topicals so longer worked for me and neither did UV treatment nor even a Caribbean holiday in the sun! It was such a relief to be able to go on a two week cruise and not to be covered in psoriasis. One more injection this month then it’ll be cold turkey. Hope withdrawal doesn’t come with a severe rebound effect putting me (us) back to square one!
According to the dr running the clinical trial, Abbott was to provide vouchers for six months’ worth of doses of Humira, free of charge. That was at the end of July 2011 – still waiting. I agree 100% with Mr. Stewart and hope that the “cold turkey” end of the trial will not bring back the disease.
For over 20 years I suffered from severe chronic plaque Psoriasis and in those 20+ years, I travelled the globe in search of a cure. This included three visits to a hospital outside Zagreb, Croatia offering Naftalan treatments, the Dead Sea, Ayurvedic treatments in Kerala, India and countless trips to locate the most barren and unpopulated salt water oasis’s where I could suntan and bathe in the hopes that my unsightly sores would heal.
As anyone who has had psoriasis can imagine, this has taken a toll on the overall quality of my life. Therefore, after abandoning any real hope of ever finding a cure I decided to leave the life that I had built for myself in Hong Kong and Asia and return back to my birthplace, Vancouver, B.C. Canada.
Not giving up, I entered myself into various homeopathic treatments, which included Colonics, Strict diets, Acupuncture, and phototherapy. None of these really had much of an impact, and therefore my Dermatologist prescribed Methotrexate. I honestly felt that by reaching the point where I was now taking a drug which was originally designed to fight Cancer, it appeared that this was my last option.
After quite a long period on Methotrexate, my body began feeling as though it was very run down. I felt like I was slowly fading away at which point I went to see my Dermatologist once again and explain that I couldn’t carry on any longer with this treatment. The timing for this visit was extremely fortuitous as Dr. Thomas explained that he knew of a Drug Trial that was to begin in the new year (2008) which sounded like it was going to be a breakthrough.
In order to be included in the trial, I needed to off all meds for a period of 3 months before the trial began and that is why I say that my visit to him to come off of Methotrexate was so incredible. Had I continued to stay on Methotrexate there was a chance that I would have never known about Abbott’s new wonder-drug, “Briakinumab”.
During the three months leading up to the trial, it was winter, the worst time of the year for anyone suffering from severe psoriasis, I was basically bed ridden. Then when the trial began, which was a double blind study, I was told that I may be on the drug when the trial begins or I may receive a placebo. After 1 1/2 months on the trial it was clear to everyone, Doctor’s and Nurse’s alike, that I was clearly on the placebo. This meant that in the 3rd month, I was guaranteed to receive the drug, and after doing so I believe that I noticed a significant calming of my psoriasis in the first two weeks, and then within a month and a half I was probably 80 – 90 percent clear. By summertime I was 100% and remained so for a glorious three years.
Then, this past spring I was told by the nurses conducting the trial that the Abbott had decided to extend the trial for close to another year which was great news. However, it was too good to be true.
I received another phone call during the summer explaining that my injection in June would be my last. Abbott was dropping the trial for reasons that I still cannot get my head around.
I’m now 46 years old and have lived over half of my life with this disease. I also understand that I’m not dying of Cancer, but to tell you the truth, unless you have psoriasis, you cannot understand the pain and suffering and therefore I have now started to go backwards at an incredible rate.
I cannot understand how there can be a drug out there that has had such an impact on my life and yet some bureaucrat with the FDA has sighted some health concerns that have led Abbott to the decision of dropping the incredibly successful trial.
It was told to me that a very high percentage of patients on this trial had complete clearing and results just like I had. Only a couple of patients died while on the trial, but those were patients that had underlying conditions. I’m not being insensitive but I think that there are other very harmful products which the government put their stamp of approval on, such as cigarettes, because of the incredible revenue that they can generate.
I am now on a mission to help try to bring this drug to those who need it. I’m also looking to see if it might be available in markets outside of North America that are not as burdened by self-satisfying organizations like the FDA.
Please feel free to contact me with any comments or advice.
Sincerely yours,
Bruce A. Bruk
My last injection was August 2011. My psoriasis is now back. My psoriasis started in 1979. Started research studies in 2002. Thanks to the research studies I was clear for 10 years. The Briakinumab was a real miracle drug for people who suffer with psoriasis. Please bring it back.
I participated in the phase III study. I was 100% clear of plaque psoriasis for the first time in twenty years. My last dose was in August. I now have a small rash on one elbow. I’m keeping fingers crossed that I won’t get a major outbreak anytime soon.
It would be helpful to see a comparison of the side effects of other biologics. Were the risks of ABT-874 really that much higher?
At least Stelara is still available..it has worked wonders for my psoriasis.
Followup from Aug. 2011 when I had my last Briakinumab injection. (Posted above.) After being off Briakinumab for around six months I have numerous tiny ‘psoriatic’ eruptions mostly on my legs. Presently using topicals am and pm. and take 4-6 mtx. per week. Result: as soon as one spot is suppressed, it seems two more come to take its place. The only good news, which makes me feel that I’m getting away with murder, is that my arms are still free of psoriasis. I thought that after six months my arms would be covered again, as they had been for over fifty years! Sure enough, as soon as I take refuge in no arm p. it’ll be back – well, hopefully not! One side -effect of being on methotrexate is the desire to sleep my life away. It’s casually mentioned that mtx. may cause fatigue or drowsiness, but this description doesn’t cut-it. This stuff makes me feel like a zombie probably feels like. I feel “jet-lag” in the middle of the day. After a good night’s sleep, I don’t want to get up in the morning as I still feel very tired.
After using Briakinumab for three years, and being 99% free of p. I feel like I’ve time-warped back into the dark age of primitive topical treatments which don’t work very well and do nothing to inhibit new eruptions. As John posted above, we should try Stelara.
(Many can’t afford to go this route though.)
The decision made to shelve Briakinumab (whatever it really was) is infuriating.
After an appointment with my derm. on Apr.23, I am disillusioned by the whole medical approach to addressing patients needs. With no Briakinumab for psoriasis now available, I find that I’m being excluded from participating in other biologic clinical trials because I was previously on a biologic, namely Briakinumab.
My derm offered me a prescription for mtx. and chloroquine. (Compared to biologics this is primitive stuff imo.) As my body and arms are still free of psoriasis I do not want to start taking Chloroquine as it is known to potentially cause flare-ups of psoriasis. Why should I throw away the clear skin that came my way via Briakinumab over the three years I took it, to take something with the potential to throw me back years due to a flare-up which, the results of which I would be stuck with????????
Something’s nor right with this scenario.