Fda Grants Fast Track For Aclaris’ Jak Inhibitors (7/9/18)

cocona

cocona

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Follicle thought article:

http://www.folliclethought.com/Updates/

More in depth article:
https://seekingalpha.com/pr/1720992...is-therapeutics-investigational-jak-inhibitor

Aclaris Therapeutics has reported today they have received a “fast track” designation from the US FDA for their topical JAK 1/3 inhibitor known as ATI-502.

According to the press release, a fast track designation is “intended to facilitate the development of new therapies for serious conditions and with the potential to address an unmet medical need. A company with an investigational medicine receiving Fast Track designation may be eligible for more frequent communications with the FDA and may receive an expedited review of the new drug application.”
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This is great we could totally have a hair loss cure by 2020 for AA.(Alopecia Areata) That would be pretty sweet. Doesn't help me a ton personally but I still definitely approve. Alcaris moving hella fast. It's only been like 3 years and already finishing up phase 2 and fast track designation. This is just ducky.
 
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cocona

cocona

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Wikipedia on FDA fast track status:

A drug that receives Fast Track designation is eligible for some or all of the following:[3]

  • More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
  • More frequent written correspondence from FDA about such things as the design of the proposed clinical trials
  • Accelerated Approval or priority review if the requisite criteria are met. Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. A fast track application is automatically considered for both of these designations.
  • Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA
An FDA decision not to grant Fast Track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research. The drug sponsor can subsequently utilize the Agency’s procedures for internal review or dispute resolution if necessary.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
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Blackber

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It’s nice to see a poential hair loss drug get fast track status from the FDA.

I’m just worried the FDA won’t consider Androgenetic Alopecia as “serious” as AA and not consider those drugs for fast track - that would suck.
 
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abcdefg

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Btg said:
yes after 2019 you dont eat propecia
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We dont know yet, but it seems to me assuming this works that some men wont respond or get better results with the big 4. In other words I think anything new will be added onto propecia not replacing it. maybe a good responder or someone early with minor male pattern baldness could just use this depending how it works, but I think propecia will be around for a very long time unless CB can replace it.
Anyways any news is good news. Hopefully it goes FAST, and gets finished so we can have new options for people that cant use propecia.
 
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Btg

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abcdefg said:
We dont know yet, but it seems to me assuming this works that some men wont respond or get better results with the big 4. In other words I think anything new will be added onto propecia not replacing it. maybe a good responder or someone early with minor male pattern baldness could just use this depending how it works, but I think propecia will be around for a very long time unless CB can replace it.
Anyways any news is good news. Hopefully it goes FAST, and gets finished so we can have new options for people that cant use propecia.
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It was sarcastic tbh but you aint wrong !
 
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alibaba92

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Blackber said:
It’s nice to see a poential hair loss drug get fast track status from the FDA.

I’m just worried the FDA won’t consider Androgenetic Alopecia as “serious” as AA and not consider those drugs for fast track - that would suck.
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It NEVER was, was it ?
 
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champpy

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20180709_231751.jpg
I tried to get into the trial. The drug they are testing for Androgenetic Alopecia is ati-50002. I attached a photo of one of the forms.
Like blackber said, its probably our luck that the Androgenetic Alopecia drug will not he fast tracked.

EDIT
Unless...is there a type error somewhere?? I just checked aclaris pipeline page and didnt see ATI-50002 even listed. If this testing company made a mistake, they did it to every damn page of the patient forms. So maybe this is for both aa and Androgenetic Alopecia...
 
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Taep

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champpy said:
View attachment 92892 I tried to get into the trial. The drug they are testing for Androgenetic Alopecia is ati-50002. I attached a photo of one of the forms.
Like blackber said, its probably our luck that the Androgenetic Alopecia drug will not he fast tracked.

EDIT
Unless...is there a type error somewhere?? I just checked aclaris pipeline page and didnt see ATI-50002 even listed. If this testing company made a mistake, they did it to every damn page of the patient forms. So maybe this is for both aa and Androgenetic Alopecia...
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Can you help me with my poor English? So you mean this is not relevant?
 
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LeeBuckler

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Did I understand this right? This is only a Treatment for Alopecia Areata NOT for Androgenetic Alopecia ???????? :((
 
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Dolph

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If it actually works for androgenetic alopecia, but is indicated for areata, doctors will be willing to prescribe it off-label (uninsured) just like they do with dutasteride, so it doesn't really matter how the FDA markets it, though it will affect cost.

Real question is: does this work for Androgenetic Alopecia or only areata.
 
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champpy

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Taep said:
Can you help me with my poor English? So you mean this is not relevant?
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Im not really sure. ATI-502 seems to be listed for multiple conditions. If its the same formulation and its fast tracked for one condition then it could be fast tracked for all conditions.
Could be... Im really just talking out my ***. But it would seem that aclaris knows they are sitting on something good.
 
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