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Amgen dump brodalumab after some patients had suicidal thoughts.

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Amgen dump brodalumab after some patients had suicidal thoughts.
Fred Offline
I Wanted To Change the World But Got Up Far Too Late.
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Treatment: Bimzelx / Coconut Oil
#1
News  Sun-24-05-2015, 12:45 PM
Brodalumab an investigational IL-17 inhibitor in development for patients with psoriasis and psoriatic arthritis has been dumped by Amgen,  they have commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca.

Quote:
Amgen announced the Company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca.  Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.  The decision was based on events of suicidal ideation and behavior in the brodalumab program, which Amgen believes likely would necessitate restrictive labeling.

"During our preparation process for regulatory submissions, we came to believe that labeling requirements likely would limit the appropriate patient population for brodalumab," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.  

After Amgen transitions the program to AstraZeneca, future decisions on the clinical development and submission of marketing applications for brodalumab will be at the sole discretion of AstraZeneca for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab.

Amgen has decided to focus its efforts and resources on other key molecules that address unmet medical needs and deliver value to patients and shareholders.  The Company continues to make progress against its strategic and financial commitments and does not expect any meaningful impact from this decision on its ability to meet them.

Source: amgen.com
jiml Offline
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#2
Sun-24-05-2015, 20:44 PM
What a shame the drug has this effect on some patients, I wonder if AstraZeneca will continue with the drug in view of this revelation... It had such good write ups with its trial against stelara
It would have been a good next step for anyone failing on Stelara
mataribot Offline
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#3
Sun-24-05-2015, 23:07 PM
(Sun-24-05-2015, 20:44 PM)jiml Wrote: What a shame the drug has this effect on some patients, I wonder if AstraZeneca will continue with the drug in view of this revelation... It had such good write ups with its trial against stelara
It would have been a good next step for anyone failing on Stelara

This article never states the drug caused the issues, just says because of what happened it would be included on package regardless.
ItchyScratchy Offline
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#4
Question  Thu-07-01-2016, 16:02 PM
this is my 1st post...so be gentle with me. Smile
as on the stage 3 Brodalumab trial in canada. Worked amazingly well - best ever treatment for me yet-totally cleared my skin and had no more PSA symptoms. Only had negative thoughts after they cancelled the study NoNo and about 6 weeks later I was fully inflamed again and quite swollen - the withdrawal was painful to say the least. After some months of total body coverage, swelling, night swearts, weight loss, etc... am now back on track with Enbrel's bridging program (3 months of free supply) also taking Leflunomide. Legs not clearing - but feel much bnetter.
Curious about anyone's experience with Lefulunomide as a solo treatmen.
Plus just learned about Cosentyx. Wondering if any of you are aware of upcoming trials for this or other IL17 inhibitors that might work for me...
With no insurance - the cost of these amazing drugs is a real issue and looking to keep both my health and wealth in balance.
Fred Offline Author
I Wanted To Change the World But Got Up Far Too Late.
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#5
Thu-07-01-2016, 16:10 PM
(Thu-07-01-2016, 16:02 PM)ItchyScratchy Wrote: this is my 1st post...so be gentle with me. Smile
as on the stage 3 Brodalumab trial in canada. Worked amazingly well - best ever treatment for me yet-totally cleared my skin and had no more PSA symptoms. Only had negative thoughts after they cancelled the study NoNo and about 6 weeks later I was fully inflamed again and quite swollen - the withdrawal was painful to say the least. After some months of total body coverage, swelling, night swearts, weight loss, etc... am now back on track with Enbrel's bridging program (3 months of free supply) also taking Leflunomide. Legs not clearing - but feel much bnetter.
Curious about anyone's experience with Lefulunomide as a solo treatmen.
Plus just learned about Cosentyx. Wondering if any of you are aware of upcoming trials for this or other IL17 inhibitors that might work for me...
With no insurance - the cost of these amazing drugs is a real issue and looking to keep both my health and wealth in balance.

Thank you for your input on Brodalumab.

Re your questions about Leflunomide it would be better to start a new thread in Prescribed Treatments For Psoriasis as it will get noticed better.

There are a few members here on Cosentyx I thought all trial were done now but again it could be worth you asking in a new thread.

Don't worry, we encourage members to open new threads as it helps keep the information relevant.

Welcome to Psoriasis Club by the way, you will find we are all gentle. Smile

Regards.

Fred.
jiml Offline
100 + Member I Just Cant Stop !

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Psoriasis Score: 3
Treatment: Skilarence 5x120mg a day
#6
Thu-07-01-2016, 16:17 PM
(Thu-07-01-2016, 16:02 PM)ItchyScratchy Wrote: this is my 1st post...so be gentle with me. Smile
as on the stage 3 Brodalumab trial in canada. Worked amazingly well - best ever treatment for me yet-totally cleared my skin and had no more PSA symptoms. Only had negative thoughts after they cancelled the study NoNo and about 6 weeks later I was fully inflamed again and quite swollen - the withdrawal was painful to say the least. After some months of total body coverage, swelling, night swearts, weight loss, etc... am now back on track with Enbrel's bridging program (3 months of free supply) also taking Leflunomide. Legs not clearing - but feel much bnetter.
Curious about anyone's experience with Lefulunomide as a solo treatmen.
Plus just learned about Cosentyx. Wondering if any of you are aware of upcoming trials for this or other IL17 inhibitors that might work for me...
With no insurance - the cost of these amazing drugs is a real issue and looking to keep both my health and wealth in balance.

We are always gentle with newcomers so  Welcome to the club/forum what a shame after a trial that psoriasis came back with a vengeance
I'm afraid I can't help with your question but thought I would just post and say hi
I'm sure someone will have some information to help

Enjoy your time with us and have a good look through the prescribed treatments
In the uk we don't have the same health system ours is free or we just pay a small amount for the drugs on prescription
Jim Thumb
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#7
Sat-26-03-2016, 02:08 AM
(Thu-07-01-2016, 16:02 PM)ItchyScratchy Wrote: this is my 1st post...so be gentle with me. Smile
as on the stage 3 Brodalumab trial in canada. Worked amazingly well - best ever treatment for me yet-totally cleared my skin and had no more PSA symptoms. Only had negative thoughts after they cancelled the study NoNo and about 6 weeks later I was fully inflamed again and quite swollen - the withdrawal was painful to say the least. After some months of total body coverage, swelling, night swearts, weight loss, etc... am now back on track with Enbrel's bridging program (3 months of free supply) also taking Leflunomide. Legs not clearing - but feel much bnetter.
Curious about anyone's experience with Lefulunomide as a solo treatmen.
Plus just learned about Cosentyx. Wondering if any of you are aware of upcoming trials for this or other IL17 inhibitors that might work for me...
With no insurance - the cost of these amazing drugs is a real issue and looking to keep both my health and wealth in balance.
Hi itchy scratchy, a fellow brodalumab survivor. Lol.  how long did you receive brodalumab?
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#8
Sat-26-03-2016, 07:53 AM
(Thu-07-01-2016, 16:02 PM)ItchyScratchy Wrote: this is my 1st post...so be gentle with me. Smile
as on the stage 3 Brodalumab trial in canada. Worked amazingly well - best ever treatment for me yet-totally cleared my skin and had no more PSA symptoms. Only had negative thoughts after they cancelled the study NoNo and about 6 weeks later I was fully inflamed again and quite swollen - the withdrawal was painful to say the least. After some months of total body coverage, swelling, night swearts, weight loss, etc... am now back on track with Enbrel's bridging program (3 months of free supply) also taking Leflunomide. Legs not clearing - but feel much bnetter.
Curious about anyone's experience with Lefulunomide as a solo treatmen.
Plus just learned about Cosentyx. Wondering if any of you are aware of upcoming trials for this or other IL17 inhibitors that might work for me...
With no insurance - the cost of these amazing drugs is a real issue and looking to keep both my health and wealth in balance.
Hi itchy scratchy. I just noticed you say your from Toronto.  Did you go to bay and bloor for brodalumab?
Bill Offline
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#9
Sun-27-03-2016, 05:14 AM
Welcome ItchyScratchy. How long did the trial go for before it was axed? How long did the brodalumab take to work for both p and psa? Also, when you say clear and no psa, does that mean no psoriasis and no pain? My apologies for the interrogation, but as the drug is new it is good to have a comparison with other drugs. I have reservations about how truthfully pharmaceutical companies portray the efficacy of their wares, so it would be nice to hear it from the horse's mouth.

Cheers,

Bill
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#10
Sun-27-03-2016, 10:52 AM
(Sun-27-03-2016, 05:14 AM)Bill Wrote: Welcome ItchyScratchy. How long did the trial go for before it was axed? How long did the brodalumab take to work for both p and psa? Also, when you say clear and no psa, does that mean no psoriasis and no pain? My apologies for the interrogation, but as the drug is new it is good to have a comparison with other drugs. I have reservations about how truthfully pharmaceutical companies portray the efficacy of their wares, so it would be nice to hear it from the horse's mouth.

Cheers,

Bill

Hi bill. I see you've tried reaching out to itchy scratchy.  If you did this on my behalf then I can't begin to thank you enough.   Bigarm  Nor can I stress enough the importance that I get in contact with this individual. I assure you and anyone that I have only the best of intentions. But, Bill, to answer your questions from my own experience this drug brought me to 99 percent clearance in under 12 weeks and sustained it for two years at which point it was canceled.  you're right to question the data, but in the case of this particular drug - It's all that and a bag of chips.
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