1. < MAC & Bronchiectasis

Brensocatib timetable to market

Posted by spider109 @spider109, Mar 4 9:09am

I recently googled Brensocatib, and found that the FDA has announced that it has a Precription Date User fee date of August 12, 2025. Now the only information I could find as to what that is, it allows the FDA can then collect money from the manufacturer (Insmed) to begin the approval process. Does anyone know if this is right? Furthermore I wonder if anyone knows possibly how long after the FDA collects their fee, would it take to get to patients with Bronchiectasis in this country and around the world. I know this is possibly the ONLY treatment specifically for Bronchiectasis, and I for one am anxious to possibly try it. Thank-you.

Interested in more discussions like this? Go to the MAC & Bronchiectasis Support Group.

help2025 | @help2025 | Mar 4 9:54am

I have not heard about this but I will look into it. Thank you for sharing.

REPLY
mustlovedogs | @mustlovedogs | Mar 4 9:56am

Found this on google
"After an FDA target action date (also known as a PDUFA date), the agency will issue a decision regarding the drug application, which can either be approval, allowing the drug to enter the market, or a "Complete Response Letter" (CRL) indicating that the application needs further revisions before approval; the FDA may also request additional information or studies to address outstanding issues depending on the review findings"

Apparently after approval it can take several months until the drug is available due to manufacturing, distribution, pricing, packaging etc. I doubt they do any of this until approval is granted. Looks like soonest it might be available if it gets approved (and not sent back for further information/revision) would be early next year? August 12th will be a big day in this forum if it gets approved.

REPLY
scoop | @scoop | Mar 4 10:17am

We are going to have to wait and see how it rolls out as there are a lot of moving part$ in a new drug process. Critical will be prior authorizations and how much medicare (or private insurance) will pay for such treatment. You can read between the lines to try to interpret what it means for us. It's aimed for patients who have 2 or more respiratory infections per year.

From my understanding Brensocatib will not replace airway clearance. It's predicted to help with inflammation and cough, and in that way, slow progression of the disease. It has the risk of increasing of lung infection. Brensocatib is a DPP1 inhibitor (reduces neutrophil activity). There are other treatments for bronchiectasis in the pipeline in addition to Brensocatib and my hope is that they will be forthcoming. My primary doctor recently warned me to not be the first in line to take Brensocatib, rather wait a bit to see how things go with it.

Interesting information can be found from in the earnings call transcript. Same company that produces ARIKAYCE.
https://seekingalpha.com/symbol/INSM

REPLY
robbiemer | @robbiemer | Mar 5 5:23pm

On Feb 27 I watched a 90 minute webinar entitled "Updates from European BE Workshop Forum on Respiratory Tract Infections". This was hosted by Mary Kitlowski of RunningonAir.org and Amy Leitman of ntminfo.org. and was sponsored by various organizations. It featured an extensive report of the conferences held in Glasgow and Paris this past February. The speaker was Prof James Chalmers of Dundee University in Glasgow.
The topics covered in fairly great detail were :
New treatments for Pseudomonas Infections
New anti-inflammatory treatments
Future treatments
It was an extremely informative and well-presented report of the new scientific findings presented at the two conferences. Brensocatib was but one of the various therapies discussed.
Fortunately there will a recording available at the end of March. I will let everyone know when I am notified.

REPLY
4 replies
spider109 | @spider109 | Mar 5 6:41pm
In reply to @robbiemer "On Feb 27 I watched a 90 minute webinar entitled "Updates from European BE Workshop Forum..." + (show)
@robbiemer

On Feb 27 I watched a 90 minute webinar entitled "Updates from European BE Workshop Forum on Respiratory Tract Infections". This was hosted by Mary Kitlowski of RunningonAir.org and Amy Leitman of ntminfo.org. and was sponsored by various organizations. It featured an extensive report of the conferences held in Glasgow and Paris this past February. The speaker was Prof James Chalmers of Dundee University in Glasgow.
The topics covered in fairly great detail were :
New treatments for Pseudomonas Infections
New anti-inflammatory treatments
Future treatments
It was an extremely informative and well-presented report of the new scientific findings presented at the two conferences. Brensocatib was but one of the various therapies discussed.
Fortunately there will a recording available at the end of March. I will let everyone know when I am notified.

Jump to this post

Yes thank-you, please do let us know, I will definitely watch it.

REPLY
irenea8 | @irenea8 | Mar 6 8:02am
In reply to @robbiemer "On Feb 27 I watched a 90 minute webinar entitled "Updates from European BE Workshop Forum..." + (show)
@robbiemer

On Feb 27 I watched a 90 minute webinar entitled "Updates from European BE Workshop Forum on Respiratory Tract Infections". This was hosted by Mary Kitlowski of RunningonAir.org and Amy Leitman of ntminfo.org. and was sponsored by various organizations. It featured an extensive report of the conferences held in Glasgow and Paris this past February. The speaker was Prof James Chalmers of Dundee University in Glasgow.
The topics covered in fairly great detail were :
New treatments for Pseudomonas Infections
New anti-inflammatory treatments
Future treatments
It was an extremely informative and well-presented report of the new scientific findings presented at the two conferences. Brensocatib was but one of the various therapies discussed.
Fortunately there will a recording available at the end of March. I will let everyone know when I am notified.

Jump to this post

Yes please let us know when it is available to listen to! Thanks!

REPLY
suzek | @suzek | Mar 6 9:59am
In reply to @robbiemer "On Feb 27 I watched a 90 minute webinar entitled "Updates from European BE Workshop Forum..." + (show)
@robbiemer

On Feb 27 I watched a 90 minute webinar entitled "Updates from European BE Workshop Forum on Respiratory Tract Infections". This was hosted by Mary Kitlowski of RunningonAir.org and Amy Leitman of ntminfo.org. and was sponsored by various organizations. It featured an extensive report of the conferences held in Glasgow and Paris this past February. The speaker was Prof James Chalmers of Dundee University in Glasgow.
The topics covered in fairly great detail were :
New treatments for Pseudomonas Infections
New anti-inflammatory treatments
Future treatments
It was an extremely informative and well-presented report of the new scientific findings presented at the two conferences. Brensocatib was but one of the various therapies discussed.
Fortunately there will a recording available at the end of March. I will let everyone know when I am notified.

Jump to this post

Thank you. Looking forward to it.

REPLY
lilianna | @lilianna | Mar 8 8:36am
In reply to @robbiemer "On Feb 27 I watched a 90 minute webinar entitled "Updates from European BE Workshop Forum..." + (show)
@robbiemer

On Feb 27 I watched a 90 minute webinar entitled "Updates from European BE Workshop Forum on Respiratory Tract Infections". This was hosted by Mary Kitlowski of RunningonAir.org and Amy Leitman of ntminfo.org. and was sponsored by various organizations. It featured an extensive report of the conferences held in Glasgow and Paris this past February. The speaker was Prof James Chalmers of Dundee University in Glasgow.
The topics covered in fairly great detail were :
New treatments for Pseudomonas Infections
New anti-inflammatory treatments
Future treatments
It was an extremely informative and well-presented report of the new scientific findings presented at the two conferences. Brensocatib was but one of the various therapies discussed.
Fortunately there will a recording available at the end of March. I will let everyone know when I am notified.

Jump to this post

Thank you

REPLY
susanreeder | @susanreeder | 4 days ago

Would like to know anything about this medication hope it gets here soon. How do I find groups of people that have information about BE.

REPLY
1 reply
View MoreView Less
Please sign in or register to post a reply.