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Pfizer PF 06651600- Breakthrough Technology Jak 3
phase 2 release of data expected sept 15, Pfizer will start phase 3 in 2019.
Replies to This Discussion
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Permalink Reply by singh on
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Hi,
what does this mean ? And why only a 5% chance a jak inhibitor will be approved by 2022??
I was really hoping for a jak inhibitor for alopecia to be approved by atleast 2020.
I think it’s a good job xeljanz patent runs out in 2020.
Thank you for the update too!
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Permalink Reply by kimk on
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To your 1 st question, we will have a much better idea what this means when we see results on Sept 15. FDA has made a statement by the Break Through Technology, seems to me the jak 3 May have done better with ct or they had more complete data vs TYK2?
2nd- Hope won’t get a drug to market, it take a lot of science, money to fund and time. Not to mention the hopeful brave individuals who qualify to be human mice.
xeljanz is a jak 1/3 this new drug is a jak3
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I thought the whole purpose of fast track and breakthrough therapy is to get a drug to market quicker? As I feel they will make billions once approved which will drive them to want to approve a drug for alopecia.
Thank you for your reply and I guess all we can do is wait.
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From the LA Times:
http://www.latimes.com/science/sciencenow/la-sci-sn-fda-expedited-d...
In a Research Letter published Tuesday in the journal JAMA, a trio of health economists from Brigham and Women's Hospital in Boston set out to test whether and how four FDA programs shortened the length time it took for proposed prescription drugs to get from their earliest clinical trials to market approval.
Of 174 drugs and biologic therapies approved between January 2012 and December 2016, 105 (or 60%) traversed the FDA evaluation process with one of four designations aimed at speeding the path to approval. The 69 candidate medications that had no such hurry-up designations took between 6.5 and 10 years to proceed from the start of human trials to FDA approval, with a midpoint of eight years.
Candidate medications evaluated under one of the four accelerated programs took between 5.1 and 10.1 years to cover the same ground, with a midpoint of 7.1 years.
Those faster speeds were largely attributable to two programs.
One, instituted in 2012, compresses clinical trials, dedicates FDA personnel to provide advice, and streamlines the FDA evaluation process for experimental drugs that may provide "breakthrough" therapy for a disease. Half of the drug candidates that got the breakthrough designation sprinted from the start of human clinical trials to FDA approval in 4.8 years or less, compared with a median start-to-finish time of eight years for drug candidates with no expedited designation.
The second, a 1997 "fast track" program, offers similar but less extensive benefits to speed drug development and evaluation time. For drug candidates that were designated for fast-tracking, the program carved about a year off the median drug development time.
Two 1992 programs designed to speed the FDA's review of drug candidates did not shorten the time it took for a drug to get from the start of human clinical trials to approval, the study found. One was the Accelerated Approval program, which allows the FDA to consider clinical trials that measure a drug's indirect effects on disease. The other was the Priority Review program, which limits the time period in which the FDA evaluates a candidate drug for approval.
UC San Francisco health economist Dr. Adams Dudley said the new research underscores that when it comes to shortening drug-development times, one key factor appears to make a difference: intensive attention from FDA evaluators. And providing that takes a commitment to staffing an agency whose budget is currently clouded in uncertainty.
The Trump administration has proposed to slash FDA funding by $854 million in 2018, but recoup that loss with revenues from drug and medical device makers who pay fees to have their products evaluated. That proposal has hit head winds in Congress.
The likely result: With growing backlogs of generic and new drugs to be evaluated, the FDA may see personnel cuts, not an expansion.
"We've constantly cut the budget and reduced personnel costs at FDA, and this research suggests it might help to get more people there," said Dudley, who directs UCSF's Center for Healthcare Value.
If giving drug candidates a speedier path through the FDA is a priority, staffing the agency for the more labor intensive task will have to come first, said Dudley.
"It's just a choice we make as a society," Dudley added. "Is it worth it to hire people who are good at testing drugs and deciding whether they work, or is it something we don't want to pay for?"
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for the record this article is from May 2017; a lot has changed between now and then. Belgravia center unfortunately doesn't make it easy to see the dates of their blog posts
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Given there are now even more potent 3rd generation things in preclinical and even the 4th generation is in the making, I would not be too pessimistic. Those people working on the 2nd generation (the products being mostly in phase 2 presently and discussed here) need to very quick - otherwise the dream of big earnings will only be an initial, short run spectacular.
In any event the existing JAKs will be available generic, off-label but affordable in the very near future.
As advised in the recent publication, it is smart to bridge the waiting time with careful intermittent use of Tofa, in order to avoid the condition getting persistent and untreatable in the future.
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Yeh I agree with you 100% Nor75 and they will make billions of a treatment for Alopecia. So all we can do is hope for a jak inhibitor to be approved and hopefully a more selective one.
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That’s true Chris, I was just stating why I thought jak inhibitors might be approved for alopecia by 2020/21 but looking at what Kim has posted that number doesn’t seem so true ..
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There is one more company trying IL-2 method (from French research).
https://bioniz.com/pipeline/bnz-1/
https://www.clinicaltrials.gov/ct2/show/NCT03532958?term=bioniz&...
SI
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